Trial Outcomes & Findings for Study of Nivolumab in Patients With Classical Hodgkin's Lymphoma (Registrational) (NCT NCT02181738)
NCT ID: NCT02181738
Last Updated: 2023-11-28
Results Overview
ORR is the percent of participants achieving either a complete remission (CR) or partial remission (PR) according to the 2007 IWG criteria. Analyses of efficacy endpoints were performed separately for each cohort, according to IWG 2007. For cohort A and B, if the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy. For cohort C, no evidence of FDG-avid disease in bone marrow was required in all participants in lieu of bone marrow aspirate/ biopsy. CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment. PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment. Confidence interval based on Clopper-Pearson method.
COMPLETED
PHASE2
294 participants
From first dose to the date of initial objectively documented progression or the date of subsequent therapy, whichever occurred first (up to approximately 28 months)
2023-11-28
Participant Flow
243 participants were treated at 34 sites in 10 countries for cohorts A, B, and C. Cohort D enrolled separately. 51 participants were treated in cohort D for a total of 294 participants treated all together.
Participant milestones
| Measure |
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)
Four doses of nivolumab flat dose 240 mg IV were administered every 2 weeks (monotherapy phase), followed by 12 doses of the combination of AVD (adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
63
|
80
|
100
|
51
|
|
Overall Study
N-AVD Combination Therapy Phase
|
0
|
0
|
0
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
13
|
45
|
|
Overall Study
NOT COMPLETED
|
63
|
80
|
87
|
6
|
Reasons for withdrawal
| Measure |
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)
Four doses of nivolumab flat dose 240 mg IV were administered every 2 weeks (monotherapy phase), followed by 12 doses of the combination of AVD (adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase).
|
|---|---|---|---|---|
|
Overall Study
Participant Withdrew Consent
|
2
|
1
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
1
|
1
|
|
Overall Study
Participant no Longer Meets Study Criteria
|
0
|
0
|
0
|
1
|
|
Overall Study
Poor/Non-Compliance
|
1
|
0
|
2
|
1
|
|
Overall Study
Disease Progression
|
28
|
35
|
40
|
0
|
|
Overall Study
Participant Request to Discontinue Study Treatment
|
5
|
12
|
5
|
1
|
|
Overall Study
Study Drug Toxicity
|
6
|
11
|
8
|
1
|
|
Overall Study
Other Reasons
|
14
|
16
|
28
|
0
|
|
Overall Study
Maximum Clinical Benefit
|
3
|
0
|
1
|
0
|
|
Overall Study
Adverse Event Unrelated to Study Drug
|
3
|
3
|
1
|
0
|
Baseline Characteristics
All treated participants
Baseline characteristics by cohort
| Measure |
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
n=63 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
n=80 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
n=100 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)
n=51 Participants
Four doses of nivolumab flat dose 240 mg IV were administered every 2 weeks (monotherapy phase), followed by 12 doses of the combination of AVD (adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase).
|
Total
n=294 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36.3 Years
STANDARD_DEVIATION 12.54 • n=5 Participants • All treated participants
|
38.7 Years
STANDARD_DEVIATION 13.00 • n=7 Participants • All treated participants
|
36.1 Years
STANDARD_DEVIATION 12.41 • n=5 Participants • All treated participants
|
39.0 Years
STANDARD_DEVIATION 16.88 • n=4 Participants • All treated participants
|
37.4 Years
STANDARD_DEVIATION 13.47 • n=21 Participants • All treated participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants • All treated participants
|
29 Participants
n=7 Participants • All treated participants
|
44 Participants
n=5 Participants • All treated participants
|
19 Participants
n=4 Participants • All treated participants
|
121 Participants
n=21 Participants • All treated participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants • All treated participants
|
51 Participants
n=7 Participants • All treated participants
|
56 Participants
n=5 Participants • All treated participants
|
32 Participants
n=4 Participants • All treated participants
|
173 Participants
n=21 Participants • All treated participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants • All treated participants
|
1 Participants
n=7 Participants • All treated participants
|
1 Participants
n=5 Participants • All treated participants
|
0 Participants
n=4 Participants • All treated participants
|
5 Participants
n=21 Participants • All treated participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants • All treated participants
|
63 Participants
n=7 Participants • All treated participants
|
56 Participants
n=5 Participants • All treated participants
|
40 Participants
n=4 Participants • All treated participants
|
189 Participants
n=21 Participants • All treated participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
30 Participants
n=5 Participants • All treated participants
|
16 Participants
n=7 Participants • All treated participants
|
43 Participants
n=5 Participants • All treated participants
|
11 Participants
n=4 Participants • All treated participants
|
100 Participants
n=21 Participants • All treated participants
|
|
Race/Ethnicity, Customized
White
|
54 Participants
n=5 Participants • All treated particpants
|
71 Participants
n=7 Participants • All treated particpants
|
86 Participants
n=5 Participants • All treated particpants
|
45 Participants
n=4 Participants • All treated particpants
|
256 Participants
n=21 Participants • All treated particpants
|
|
Race/Ethnicity, Customized
Black or African
|
2 Participants
n=5 Participants • All treated particpants
|
4 Participants
n=7 Participants • All treated particpants
|
6 Participants
n=5 Participants • All treated particpants
|
2 Participants
n=4 Participants • All treated particpants
|
14 Participants
n=21 Participants • All treated particpants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants • All treated particpants
|
1 Participants
n=7 Participants • All treated particpants
|
5 Participants
n=5 Participants • All treated particpants
|
2 Participants
n=4 Participants • All treated particpants
|
11 Participants
n=21 Participants • All treated particpants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants • All treated particpants
|
0 Participants
n=7 Participants • All treated particpants
|
2 Participants
n=5 Participants • All treated particpants
|
0 Participants
n=4 Participants • All treated particpants
|
2 Participants
n=21 Participants • All treated particpants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • All treated particpants
|
0 Participants
n=7 Participants • All treated particpants
|
0 Participants
n=5 Participants • All treated particpants
|
0 Participants
n=4 Participants • All treated particpants
|
0 Participants
n=21 Participants • All treated particpants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants • All treated particpants
|
4 Participants
n=7 Participants • All treated particpants
|
1 Participants
n=5 Participants • All treated particpants
|
2 Participants
n=4 Participants • All treated particpants
|
11 Participants
n=21 Participants • All treated particpants
|
PRIMARY outcome
Timeframe: From first dose to the date of initial objectively documented progression or the date of subsequent therapy, whichever occurred first (up to approximately 28 months)Population: All treated Cohort A, B and C participants
ORR is the percent of participants achieving either a complete remission (CR) or partial remission (PR) according to the 2007 IWG criteria. Analyses of efficacy endpoints were performed separately for each cohort, according to IWG 2007. For cohort A and B, if the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy. For cohort C, no evidence of FDG-avid disease in bone marrow was required in all participants in lieu of bone marrow aspirate/ biopsy. CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment. PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment. Confidence interval based on Clopper-Pearson method.
Outcome measures
| Measure |
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
n=63 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
n=80 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
n=100 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
|---|---|---|---|
|
Objective Response Rate (ORR) Based on IRRC Assessments in Cohorts A, B, and C
|
65.1 Percentage of Particpants
Interval 52.0 to 76.7
|
67.5 Percentage of Particpants
Interval 56.1 to 77.6
|
73.0 Percentage of Particpants
Interval 63.2 to 81.4
|
PRIMARY outcome
Timeframe: From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months)Population: All Cohort D participants treated in the monotherapy and combination therapy phases.
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug 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 drug, whether or not considered related to the study drug.
Outcome measures
| Measure |
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
n=51 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
|---|---|---|---|
|
Number of Participants Who Experienced at Least One Treatment Related Grade 3-5 AE in Cohort D
Monotherapy
|
0 Participants
|
—
|
—
|
|
Number of Participants Who Experienced at Least One Treatment Related Grade 3-5 AE in Cohort D
Combination Therapy (receiving AVD or NAVD)
|
30 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months).Population: All treated Cohort A, B and C participants with objective response of CR or PR.
DOR is the time from first response (complete remission (CR) or partial remission (PR)) to the date of initial objectively documented progression as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. For participants who neither progressed nor died, the DOR was censored on the date of their last tumor assessment. Participants who started subsequent therapy without a prior reported progression were censored at the last tumor assessments prior to initiation of the subsequent anticancer therapy. CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment. PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment. Computed using Kaplan-Meier method.
Outcome measures
| Measure |
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
n=41 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
n=57 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
n=75 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
|---|---|---|---|
|
Duration of Objective Response Based on IRRC Assessments in Cohorts A, B, and C
|
26.18 Months
Interval 15.21 to
The upper 95% confidence interval was not reached due to Insufficient number of participants with events to reach the threshold according to Kaplan-Meier methodology.
|
16.59 Months
Interval 9.26 to 25.72
|
18.17 Months
Interval 11.63 to 30.85
|
SECONDARY outcome
Timeframe: From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)Population: All treated Cohort A, B and C participants
The CR rate was defined as the percent of participants with a BOR of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment. Confidence interval based on Clopper-Pearson method.
Outcome measures
| Measure |
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
n=63 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
n=80 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
n=100 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
|---|---|---|---|
|
Complete Remission (CR) Rate Based on IRRC Assessments in Cohorts A, B, and C
|
31.7 Percentage of Participants
Interval 20.6 to 44.7
|
13.8 Percentage of Participants
Interval 7.1 to 23.3
|
21 Percentage of Participants
Interval 13.5 to 30.3
|
SECONDARY outcome
Timeframe: From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)Population: All treated Cohort A, B and C participants who had a BOR of CR.
The duration of CR was only evaluated in participants with BOR of CR and was defined as the time from first documentation of CR (the date of first negative FDG-PET scan or the date of first documentation of no disease involvement in the bone marrow (if required), whichever occurred later) to the date of initial objectively documented progression (Any new lesion or increase by \>=50% of previously involved sites from nadir) as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. Censoring was applied as per DOR definition. Computed using Kaplan-Meier method.
Outcome measures
| Measure |
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
n=20 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
n=11 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
n=21 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
|---|---|---|---|
|
Duration of Complete Remission (CR) Based on IRRC Assessments for Cohorts A, B, and C
|
43.47 Months
Interval 18.0 to
The upper 95% confidence interval was not reached due to Insufficient number of participants with events to reach the threshold according to Kaplan-Meier methodology.
|
30.32 Months
Interval 2.4 to
The upper 95% confidence interval was not reached due to Insufficient number of participants with events to reach the threshold according to Kaplan-Meier methodology.
|
26.41 Months
Interval 7.13 to
The upper 95% confidence interval was not reached due to Insufficient number of participants with events to reach the threshold according to Kaplan-Meier methodology.
|
SECONDARY outcome
Timeframe: From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)Population: All treated Cohort A, B and C participants
The PR rate was defined as the percent of participants with a BOR of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment. Confidence interval based on Clopper-Pearson method.
Outcome measures
| Measure |
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
n=63 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
n=80 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
n=100 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
|---|---|---|---|
|
Partial Remission (PR) Rate Based on IRRC Assessments in Cohorts A, B, and C
|
33.3 Percentage of Participants
Interval 22.0 to 46.3
|
57.5 Percentage of Participants
Interval 45.9 to 68.5
|
54.0 Percentage of Participants
Interval 43.7 to 64.0
|
SECONDARY outcome
Timeframe: From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)Population: All treated Cohort A, B and C participants who had a BOR of PR.
The duration of PR was only evaluated in participants with BOR of PR and was defined as the time from first documentation of PR (regression of measurable disease and no new sites) to the date of initial objectively documented progression (any new lesion or increase by \>=50% of previously involved sites from nadir) as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. Censoring was applied as per DOR definition. Computed using Kaplan-Meier method.
Outcome measures
| Measure |
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
n=21 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
n=46 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
n=54 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
|---|---|---|---|
|
Duration of PR Based on IRRC Assessments in Cohorts A, B, and C
|
12.78 Months
Interval 4.17 to 27.17
|
10.58 Months
Interval 7.46 to 25.26
|
14.65 Months
Interval 9.36 to 30.36
|
SECONDARY outcome
Timeframe: From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)Population: All treated Cohort A, B and C participants
ORR is the percent of participants achieving either a complete remission (CR) or partial remission (PR) according to the 2007 IWG criteria. Analyses of efficacy endpoints were performed separately for each cohort, according to IWG 2007. For cohort A and B, if the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy. For cohort C, no evidence of FDG-avid disease in bone marrow was required in all participants in lieu of bone marrow aspirate/ biopsy. CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment. PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment. Confidence interval based on Clopper-Pearson method.
Outcome measures
| Measure |
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
n=63 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
n=80 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
n=100 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
|---|---|---|---|
|
Objective Response Rates (ORR) Based on Investigator Assessments for Cohorts A, B, and C
|
69.8 Percentage of Participants
Interval 57.0 to 80.8
|
73.8 Percentage of Participants
Interval 62.7 to 83.0
|
70.0 Percentage of Participants
Interval 60.0 to 78.8
|
SECONDARY outcome
Timeframe: From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)Population: All treated Cohort A, B and C participants who had a BOR of CR or PR.
DOR is the time from first response (complete remission (CR) or partial remission (PR)) to the date of initial objectively documented progression as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. For participants who neither progressed nor died, the DOR was censored on the date of their last tumor assessment. Participants who started subsequent therapy without a prior reported progression were censored at the last tumor assessments prior to initiation of the subsequent anticancer therapy. CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment. PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment. Computed using Kaplan-Meier method.
Outcome measures
| Measure |
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
n=44 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
n=59 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
n=70 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
|---|---|---|---|
|
Duration of Objective Response (DOR) Based on Investigator Assessments in Cohorts A, B, and C
|
39.10 Months
Interval 16.59 to 78.29
|
25.26 Months
Interval 10.09 to 41.72
|
28.85 Months
Interval 12.02 to 34.53
|
SECONDARY outcome
Timeframe: From first dose up until the date of treatment discontinuation (up to approximately 100 months).Population: All Cohort D participants treated in the monotherapy and combination therapy phases.
Treatment discontinuation rate (TDR) is the number of treated participants who received \<4 doses of monotherapy or \<12 doses of their assigned combination regimen. A participant is considered as having received an AVD/NAVD dose as soon as they received at least one drug of AVD/NAVD for the considered dose. Participants must have received at least one dose of Nivolumab during the combination therapy phase to be included in participants treated with NAVD. If a participant subsequently met Criteria to Resume Nivolumab Dosing, the combination of nivolumab and AVD could be used. Participants who underwent treatment beyond progression during the Monotherapy phase could use the combination of nivolumab and AVD if all 4 doses of nivolumab monotherapy are completed. Discontinuation can be due to any reason including, but not limited to, drug-related toxicity, diseases progression, or death.
Outcome measures
| Measure |
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
n=51 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
|---|---|---|---|
|
Treatment Discontinuation Rate in Cohort D
Monotherapy
|
2 Participants
|
—
|
—
|
|
Treatment Discontinuation Rate in Cohort D
Combination Therapy (receiving AVD or NAVD)
|
5 Participants
|
—
|
—
|
|
Treatment Discontinuation Rate in Cohort D
Combination Therapy (NAVD receivers only)
|
5 Participants
|
—
|
—
|
|
Treatment Discontinuation Rate in Cohort D
Overall Therapy
|
6 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of the considered therapy phase to 100 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 10 months up to a maximum of 13 months)Population: All Cohort D participants treated in the monotherapy and combination therapy phases.
Number of participants who died in Cohort D within 100 days after last dose of study therapy.
Outcome measures
| Measure |
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
n=51 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
|---|---|---|---|
|
Number of Participants Who Died in Cohort D
Monotherapy
|
0 Participants
|
—
|
—
|
|
Number of Participants Who Died in Cohort D
Combination Therapy (receiving AVD or NAVD)
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months)Population: All treated participants in Cohort D
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 drug 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 drug, whether or not considered related to the study drug. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Outcome measures
| Measure |
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
n=51 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) in Cohort D
Monotherapy
|
48 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) in Cohort D
Combination Therapy (receiving AVD or NAVD)
|
49 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months)Population: All treated participants in Cohort D
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Outcome measures
| Measure |
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
n=51 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) in Cohort D
Monotherapy
|
2 Participants
|
—
|
—
|
|
Number of Participants With Serious Adverse Events (SAEs) in Cohort D
Combination Therapy (receiving AVD or NAVD)
|
10 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months)Population: All treated participants in Cohort D
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 drug 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 drug, whether or not considered related to the study drug. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Outcome measures
| Measure |
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
n=51 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
|---|---|---|---|
|
Number of Participants With AEs Leading to Discontinuation in Cohort D
Monotherapy
|
1 Participants
|
—
|
—
|
|
Number of Participants With AEs Leading to Discontinuation in Cohort D
Combination Therapy (receiving AVD or NAVD)
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months)Population: All treated participants in Cohort D
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 drug 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 drug, whether or not considered related to the study drug. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Outcome measures
| Measure |
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
n=51 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
|---|---|---|---|
|
Number of Participants With AEs Leading to Dose Delay in Cohort D
Monotherapy
|
3 Participants
|
—
|
—
|
|
Number of Participants With AEs Leading to Dose Delay in Cohort D
Combination Therapy (receiving AVD or NAVD)
|
29 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months)Population: All treated participants in Cohort D
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 drug 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 drug, whether or not considered related to the study drug. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Select AEs have been categorized into seven areas: pulmonary toxicity, gastrointestinal toxicity, hepatotoxicity, endocrinopathy, skin toxicity, neurological toxicity and renal toxicity. Select AEs, in particular pneumonitis, are considered clinically meaningful as they require greater vigilance and for early recognition and prompt intervention.
Outcome measures
| Measure |
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
n=51 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
|---|---|---|---|
|
Number of Participants With Select AEs in Cohort D
Gastrointestinal Monotherapy
|
6 Participants
|
—
|
—
|
|
Number of Participants With Select AEs in Cohort D
Gastrointestinal Combination Therapy
|
13 Participants
|
—
|
—
|
|
Number of Participants With Select AEs in Cohort D
Hepatic Monotherapy
|
2 Participants
|
—
|
—
|
|
Number of Participants With Select AEs in Cohort D
Hepatic Combination Therapy
|
3 Participants
|
—
|
—
|
|
Number of Participants With Select AEs in Cohort D
Pulmonary Monotherapy
|
0 Participants
|
—
|
—
|
|
Number of Participants With Select AEs in Cohort D
Pulmonary Combination Therapy
|
3 Participants
|
—
|
—
|
|
Number of Participants With Select AEs in Cohort D
Renal Monotherapy
|
1 Participants
|
—
|
—
|
|
Number of Participants With Select AEs in Cohort D
Renal Combination Therapy
|
0 Participants
|
—
|
—
|
|
Number of Participants With Select AEs in Cohort D
Skin Monotherapy
|
17 Participants
|
—
|
—
|
|
Number of Participants With Select AEs in Cohort D
Skin Combination Therapy
|
9 Participants
|
—
|
—
|
|
Number of Participants With Select AEs in Cohort D
Hypersensitivity/Infusion Reactions Monotherapy
|
16 Participants
|
—
|
—
|
|
Number of Participants With Select AEs in Cohort D
Hypersensitivity/Infusion Reactions Combination
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of monotherapy to 30 days after last dose of monotherapy phase (up to approximately 3 months)Population: All participants treated in the Cohort D monotherapy phase who had at least one on-treatment TSH measurement during the monotherapy phase
The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
Outcome measures
| Measure |
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
n=42 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Monotherapy Phase
TSH > ULN
|
1 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Monotherapy Phase
TSH > ULN WITH TSH <= ULN AT BASELINE
|
1 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Monotherapy Phase
TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Monotherapy Phase
TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Monotherapy Phase
TSH > ULN WITH FT3/FT4 TEST MISSING
|
1 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Monotherapy Phase
TSH < LLN
|
5 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Monotherapy Phase
TSH <LLN WITH TSH >= LLN AT BASELINE
|
5 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Monotherapy Phase
TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN
|
1 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Monotherapy Phase
TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Monotherapy Phase
TSH < LLN WITH FT3/FT4 TEST MISSING
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of the combination therapy to 30 days after last dose of combination therapy (an average of 8 months and a maximum of 11 months)Population: All participants treated in the Cohort D combination therapy phase who had at least one on-treatment AST, ALT and/or bilirubin test measurement during the combination therapy phase
The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
Outcome measures
| Measure |
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
n=48 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
|---|---|---|---|
|
Number of Participants Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Combination Therapy Phase
TSH > ULN
|
12 Participants
|
—
|
—
|
|
Number of Participants Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Combination Therapy Phase
TSH > ULN WITH TSH <= ULN AT BASELINE
|
8 Participants
|
—
|
—
|
|
Number of Participants Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Combination Therapy Phase
TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN
|
3 Participants
|
—
|
—
|
|
Number of Participants Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Combination Therapy Phase
TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN
|
1 Participants
|
—
|
—
|
|
Number of Participants Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Combination Therapy Phase
TSH > ULN WITH FT3/FT4 TEST MISSING
|
8 Participants
|
—
|
—
|
|
Number of Participants Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Combination Therapy Phase
TSH < LLN
|
5 Participants
|
—
|
—
|
|
Number of Participants Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Combination Therapy Phase
TSH <LLN WITH TSH >= LLN AT BASELINE
|
5 Participants
|
—
|
—
|
|
Number of Participants Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Combination Therapy Phase
TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN
|
1 Participants
|
—
|
—
|
|
Number of Participants Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Combination Therapy Phase
TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN
|
0 Participants
|
—
|
—
|
|
Number of Participants Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Combination Therapy Phase
TSH < LLN WITH FT3/FT4 TEST MISSING
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of monotherapy to 30 days after last dose of monotherapy phase (up to approximately 3 months)Population: All participants treated in the Cohort D monotherapy phase
The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase, AST = Aspartate Aminotransferase, ULN = Upper Limit of Normal.
Outcome measures
| Measure |
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
n=51 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Monotherapy Phase
ALT OR AST > 3XULN
|
2 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Monotherapy Phase
ALT OR AST> 5XULN
|
1 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Monotherapy Phase
ALT OR AST> 10XULN
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Monotherapy Phase
ALT OR AST > 20XULN
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Monotherapy Phase
TOTAL BILIRUBIN > 2XULN
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Monotherapy Phase
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Monotherapy Phase
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of the combination therapy to 30 days after last dose of combination therapy (an average of 8 months and a maximum of 11 months)Population: All participants treated in the Cohort D combination therapy phase with at least one on-treatment laboratory measurement
The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase, AST = Aspartate Aminotransferase, ULN = Upper Limit of Normal.
Outcome measures
| Measure |
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
n=49 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Combination Therapy Phase
ALT OR AST> 10XULN
|
1 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Combination Therapy Phase
ALT OR AST > 3XULN
|
4 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Combination Therapy Phase
ALT OR AST> 5XULN
|
1 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Combination Therapy Phase
ALT OR AST > 20XULN
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Combination Therapy Phase
TOTAL BILIRUBIN > 2XULN
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Combination Therapy Phase
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Combination Therapy Phase
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)Population: All Cohort D participants treated in the monotherapy and combination therapy phases.
CR rate is the percent of participants who show CR (disappearance of all evidence of disease) according to the 2007 IWG criteria at the planned end of study therapy radiographic tumor assessment. Confidence interval based on the Klopper and Pearson method.
Outcome measures
| Measure |
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
n=51 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
|---|---|---|---|
|
Complete Response (CR) Rate at Planned End of Therapy Based on IRRC Assessments in Cohort D
|
66.7 Percent of Participants
Interval 52.1 to 79.2
|
—
|
—
|
POST_HOC outcome
Timeframe: From first dose to the date of initial objectively documented progression or the date of subsequent therapy, whichever occurred first (up to approximately 100 months)Population: All treated Cohort A, B and C participants
Represents an updated version of the primary endpoint to include additional data collection that occurred after the primary completion date. (Assessments were made until 30 Nov 2022). Clinical benefit of nivolumab, as measured by ORR per IRRC assessment, and defined as percent of participants achieving either complete remission (CR) or partial remission (PR) according to the 2007 IWG criteria. For cohort A and B, if the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy. For cohort C, no evidence of FDG-avid disease in bone marrow was required in all patients in lieu of bone marrow aspirate/ biopsy. CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria. PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria.
Outcome measures
| Measure |
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
n=63 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
n=80 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
n=100 Participants
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
|---|---|---|---|
|
Objective Response Rate (ORR) Based on IRRC Assessments in Cohorts A, B, and C Extended Collection
|
65.1 Percentage of Participants
Interval 52.0 to 76.7
|
71.3 Percentage of Participants
Interval 60.0 to 80.8
|
75.0 Percentage of Participants
Interval 65.3 to 83.1
|
Adverse Events
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin- Nivolumab 3 mg/kg
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin-Nivolumab 240 mg
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin-Nivolumab 480 mg
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Stem Cell Transplant-Nivolumab 3 mg/kg
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Stem Cell Transplant-Nivolumab 240 mg
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Stem Cell Transplant- Nivolumab 480 mg
Cohort C: Post Transplant, Brentuximab Vedotin Pre-and/or Post-SC Transplant - Nivolumab 3 mg/kg
Cohort C: Post Transplant, Brentuximab Vedotin Pre-and/Post-Stem Cell Transplant - Nivolumab 240 mg
Cohort C: Post Transplant, Brentuximab Vedotin Pre-and/Post-Stem Cell Transplant - Nivolumab 480 mg
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)
Serious adverse events
| Measure |
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin- Nivolumab 3 mg/kg
n=46 participants at risk
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin-Nivolumab 240 mg
n=9 participants at risk
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin-Nivolumab 480 mg
n=8 participants at risk
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Stem Cell Transplant-Nivolumab 3 mg/kg
n=75 participants at risk
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Stem Cell Transplant-Nivolumab 240 mg
n=3 participants at risk
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Stem Cell Transplant- Nivolumab 480 mg
n=2 participants at risk
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Pre-and/or Post-SC Transplant - Nivolumab 3 mg/kg
n=84 participants at risk
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Pre-and/Post-Stem Cell Transplant - Nivolumab 240 mg
n=13 participants at risk
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Pre-and/Post-Stem Cell Transplant - Nivolumab 480 mg
n=3 participants at risk
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)
n=51 participants at risk
Four doses of nivolumab flat dose 240 mg IV were administered every 2 weeks (monotherapy phase), followed by 12 doses of the combination of AVD (adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.9%
2/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastritis
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Generalised oedema
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Pyrexia
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.0%
3/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.6%
3/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
3/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Systemic inflammatory response syndrome
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Immune system disorders
Acute graft versus host disease
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Immune system disorders
Graft versus host disease
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Cystitis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Device related sepsis
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Hepatitis A
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Influenza
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.9%
2/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Lyme disease
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Meningitis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.7%
5/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.0%
5/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Sepsis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Lipase increased
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Platelet count decreased
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Respirovirus test positive
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue disorder
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular lymphoma stage III
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.8%
4/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma of the skin
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peripheral T-cell lymphoma unspecified
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Seizure
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Syncope
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.6%
3/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheomalacia
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Embolism
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
Other adverse events
| Measure |
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin- Nivolumab 3 mg/kg
n=46 participants at risk
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin-Nivolumab 240 mg
n=9 participants at risk
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin-Nivolumab 480 mg
n=8 participants at risk
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Stem Cell Transplant-Nivolumab 3 mg/kg
n=75 participants at risk
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Stem Cell Transplant-Nivolumab 240 mg
n=3 participants at risk
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Stem Cell Transplant- Nivolumab 480 mg
n=2 participants at risk
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Pre-and/or Post-SC Transplant - Nivolumab 3 mg/kg
n=84 participants at risk
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Pre-and/Post-Stem Cell Transplant - Nivolumab 240 mg
n=13 participants at risk
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort C: Post Transplant, Brentuximab Vedotin Pre-and/Post-Stem Cell Transplant - Nivolumab 480 mg
n=3 participants at risk
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
|
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)
n=51 participants at risk
Four doses of nivolumab flat dose 240 mg IV were administered every 2 weeks (monotherapy phase), followed by 12 doses of the combination of AVD (adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.7%
4/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
16.0%
12/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
21.4%
18/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.4%
2/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
17.6%
9/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.8%
4/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.0%
3/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.7%
4/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.3%
7/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
10.7%
9/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.4%
2/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
54.9%
28/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.5%
3/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.0%
3/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
16.7%
14/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Palpitations
|
6.5%
3/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.6%
3/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.9%
2/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.3%
7/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Ear and labyrinth disorders
Ear pain
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.3%
4/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Ear and labyrinth disorders
Tinnitus
|
6.5%
3/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Ear and labyrinth disorders
Vertigo
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.9%
2/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hyperthyroidism
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.6%
3/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
3/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hypothyroidism
|
15.2%
7/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.0%
9/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
7/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.4%
2/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.7%
8/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Primary hypothyroidism
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.0%
3/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Dry eye
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.0%
3/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
7/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Eye disorder
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Mydriasis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Vision blurred
|
6.5%
3/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.8%
4/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.8%
4/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Visual field defect
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.9%
2/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.0%
3/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.2%
7/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.7%
14/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.5%
13/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.8%
4/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
13.0%
6/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
3/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.6%
3/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
15.2%
7/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
22.2%
2/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.7%
14/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
17.9%
15/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
35.3%
18/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
56.5%
26/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
3/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
62.5%
5/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
49.3%
37/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
100.0%
2/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
29.8%
25/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
46.2%
6/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
17/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dry mouth
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.0%
3/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.8%
4/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
3/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.7%
4/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.7%
5/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.0%
5/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.8%
4/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.7%
5/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Flatulence
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastritis
|
6.5%
3/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.3%
7/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.8%
4/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.9%
2/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
3/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
30.4%
14/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
62.5%
5/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
26.7%
20/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
22.6%
19/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
60.8%
31/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Steatorrhoea
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
10.9%
5/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.0%
3/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.8%
4/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
23.5%
12/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Toothache
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.7%
5/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
3/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
23.9%
11/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
22.2%
2/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
62.5%
5/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
24.0%
18/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
22.6%
19/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
29.4%
15/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Asthenia
|
8.7%
4/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
2/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.0%
9/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.6%
3/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
13.7%
7/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Chest discomfort
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.6%
3/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.9%
2/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Chest pain
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.6%
3/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.8%
4/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Chills
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
3/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.3%
4/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.8%
4/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
23.1%
3/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.8%
6/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
41.3%
19/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
55.6%
5/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
37.5%
3/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
48.0%
36/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
100.0%
2/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
32.1%
27/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.4%
2/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
37.3%
19/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Feeling cold
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
22.2%
2/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Illness
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Inflammation
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Influenza like illness
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
37.5%
3/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.7%
5/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Malaise
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
22.2%
2/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.6%
3/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Mucosal dryness
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Mucosal inflammation
|
8.7%
4/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.0%
3/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.8%
5/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Non-cardiac chest pain
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Oedema peripheral
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.0%
6/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
13.1%
11/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.9%
2/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Pain
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.0%
6/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.8%
4/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
3/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Peripheral swelling
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
2/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.3%
4/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.6%
3/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Pyrexia
|
26.1%
12/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
55.6%
5/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
37.5%
3/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
44.0%
33/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
100.0%
2/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
34.5%
29/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.4%
2/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
39.2%
20/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Thirst
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Venoocclusive liver disease
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Immune system disorders
Hypersensitivity
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
2/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.9%
2/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Immune system disorders
Seasonal allergy
|
6.5%
3/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Aeromonas infection
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Atypical mycobacterial infection
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Bronchitis
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
22.2%
2/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
37.5%
3/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.0%
6/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
COVID-19
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
2/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.7%
5/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.3%
4/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.6%
3/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Cystitis
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Folliculitis
|
6.5%
3/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.0%
3/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Gastric infection
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.0%
3/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.9%
2/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.7%
5/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Herpes simplex
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Herpes zoster
|
8.7%
4/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
2/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.6%
3/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.4%
2/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Infection
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Influenza
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
3/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.7%
5/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.0%
5/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Lip infection
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
2/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Lymph gland infection
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
21.7%
10/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
55.6%
5/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
75.0%
6/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
28.0%
21/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
100.0%
3/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.9%
10/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
23.1%
3/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.8%
6/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.0%
3/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.6%
3/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pharyngitis
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.6%
3/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
3/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pharyngitis bacterial
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia
|
8.7%
4/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
17.3%
13/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.1%
6/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
3/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.3%
4/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
3/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Rhinitis
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
3/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.0%
6/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.6%
3/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Septic shock
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Sinusitis
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
3/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.0%
6/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.8%
4/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Skin infection
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.0%
3/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
23.9%
11/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
37.5%
3/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
37.3%
28/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
21.4%
18/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
23.1%
3/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.8%
6/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
6.5%
3/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.3%
7/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.6%
3/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Viral infection
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.7%
5/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.4%
2/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
13.0%
6/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
17.3%
13/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
10.7%
9/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
31.4%
16/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Skin procedural complication
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
13.0%
6/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
22.2%
2/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
2/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
14.7%
11/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
10.7%
9/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
3/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Amylase increased
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.3%
7/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.6%
3/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
3/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
8.7%
4/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
2/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.0%
9/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.9%
10/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.9%
2/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood alkaline phosphatase increased
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.0%
6/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.5%
8/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.3%
4/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood creatinine increased
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.0%
6/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.6%
3/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.0%
3/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Lipase increased
|
8.7%
4/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
21.3%
16/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.8%
4/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.9%
2/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Liver function test increased
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Lymphocyte count decreased
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.0%
3/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.0%
5/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
3/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
2/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.3%
4/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
19.6%
10/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Platelet count decreased
|
10.9%
5/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.6%
3/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.4%
2/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Sputum abnormal
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Transaminases increased
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Weight decreased
|
6.5%
3/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
37.5%
3/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.0%
6/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.8%
4/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Weight increased
|
6.5%
3/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.3%
7/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.5%
8/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
White blood cell count decreased
|
6.5%
3/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.0%
3/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.6%
3/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
17.6%
9/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.9%
5/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
3/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
2/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
14.7%
11/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
7/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
3/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.6%
3/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.5%
3/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
10.7%
8/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
7/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
3/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.5%
3/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.0%
6/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.8%
4/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.9%
2/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.7%
5/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.8%
4/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.9%
2/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.1%
6/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.6%
9/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
44.4%
4/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
2/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
36.0%
27/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
17.9%
15/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
21.6%
11/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.4%
8/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
2/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
22.7%
17/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
14.3%
12/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.7%
8/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.6%
3/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.7%
8/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
22.2%
2/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.3%
4/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.5%
3/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
14.7%
11/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.0%
5/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle swelling
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.8%
4/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.9%
2/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.2%
7/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
2/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
14.7%
11/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
10.7%
9/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
13.7%
7/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.5%
3/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.0%
6/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
7/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
3/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Convulsions local
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
13.0%
6/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
13.3%
10/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
7/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.7%
8/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Dysaesthesia
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
30.4%
14/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
3/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
2/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
20.0%
15/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.5%
13/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
23.1%
3/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
13.7%
7/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.7%
5/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Lethargy
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Memory impairment
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.6%
3/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
3/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Migraine
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.0%
3/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Neuropathy peripheral
|
6.5%
3/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.0%
9/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.6%
3/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.8%
5/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.0%
3/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.8%
4/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Polyneuropathy
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
3/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Syncope
|
6.5%
3/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Tremor
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.7%
5/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.0%
5/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
3/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Depressed mood
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Depression
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.7%
5/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.8%
4/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
8.7%
4/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
16.0%
12/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
100.0%
2/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
7/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.8%
5/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Dysuria
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.3%
4/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.6%
3/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Pollakiuria
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
45.7%
21/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
55.6%
5/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
4/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
41.3%
31/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
28/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
38.5%
5/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.5%
13/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
37.5%
3/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.7%
4/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
22.2%
2/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.7%
14/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.5%
13/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
23.1%
3/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.8%
6/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.0%
3/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.6%
3/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.9%
2/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.6%
3/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Increased viscosity of upper respiratory secretion
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
19.6%
9/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
62.5%
5/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.0%
9/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.5%
8/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
3/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
13.0%
6/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
3/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
2/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.7%
14/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
13.1%
11/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.9%
2/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus inflammation
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.0%
6/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.8%
4/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.7%
4/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
22.2%
2/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
37.5%
3/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.0%
6/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.8%
4/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.3%
4/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.8%
4/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.7%
5/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.5%
8/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.5%
3/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
37.5%
3/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.0%
3/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.8%
4/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
3/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.3%
4/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
2/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
2/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.0%
3/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
22.2%
2/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.0%
3/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
4/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.0%
6/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.0%
5/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.8%
4/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.9%
5/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.8%
4/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
23.1%
3/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
3/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
3/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
6.5%
3/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
3/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.3%
4/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.8%
4/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
23.9%
11/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
3/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
29.3%
22/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
16.7%
14/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
23.1%
3/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
23.5%
12/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
26.1%
12/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
2/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
28.0%
21/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.5%
13/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.4%
2/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.5%
13/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.9%
5/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.3%
4/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
3/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.0%
3/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.6%
3/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Flushing
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Hot flush
|
2.2%
1/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.8%
4/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Hypertension
|
4.3%
2/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.7%
5/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.9%
2/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.7%
2/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.0%
1/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/46 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.1%
1/9 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/75 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/84 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/51 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
Additional Information
Bristol Myers Squibb Study Director
Bristol Myers Squibb
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER