Trial Outcomes & Findings for Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017) (NCT NCT01642004)
NCT ID: NCT01642004
Last Updated: 2022-12-28
Results Overview
OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
272 participants
Primary outcome timeframe
Randomization until 199 deaths, up to November 2014, approximately 25 months
Results posted on
2022-12-28
Participant Flow
Participant milestones
| Measure |
Nivolumab
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
|
Docetaxel
Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
|
|---|---|---|
|
Randomization
STARTED
|
135
|
137
|
|
Randomization
COMPLETED
|
131
|
129
|
|
Randomization
NOT COMPLETED
|
4
|
8
|
|
Treatment
STARTED
|
131
|
129
|
|
Treatment
Participants Transitioned to Nivolumab
|
0
|
6
|
|
Treatment
COMPLETED
|
0
|
0
|
|
Treatment
NOT COMPLETED
|
131
|
129
|
Reasons for withdrawal
| Measure |
Nivolumab
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
|
Docetaxel
Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
|
|---|---|---|
|
Randomization
Adverse Event unrelated to study drug
|
1
|
0
|
|
Randomization
Participant withdrew consent
|
1
|
6
|
|
Randomization
No longer meets study criteria
|
2
|
2
|
|
Treatment
Disease progression
|
95
|
79
|
|
Treatment
Study drug toxicity
|
10
|
13
|
|
Treatment
Death
|
1
|
1
|
|
Treatment
Adverse event unrelated to study drug
|
9
|
13
|
|
Treatment
Maximum clinical benefit
|
1
|
9
|
|
Treatment
Poor/non-compliance
|
1
|
0
|
|
Treatment
No longer meets study criteria
|
1
|
2
|
|
Treatment
Other reasons
|
2
|
0
|
|
Treatment
Not reported
|
0
|
3
|
|
Treatment
Participant request to discontinue study treatment
|
6
|
4
|
|
Treatment
Participant withdrew consent
|
5
|
5
|
Baseline Characteristics
Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017)
Baseline characteristics by cohort
| Measure |
Nivolumab
n=135 Participants
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
|
Docetaxel
n=137 Participants
Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
|
Total
n=272 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.2 years
STANDARD_DEVIATION 8.33 • n=5 Participants
|
64.4 years
STANDARD_DEVIATION 8.28 • n=7 Participants
|
63.3 years
STANDARD_DEVIATION 8.36 • n=5 Participants
|
|
Age, Customized
<= 18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
< 65 years
|
79 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Age, Customized
>= 65 AND < 75 years
|
45 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Age, Customized
>= 75 AND < 85 years
|
10 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Customized
>= 85 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
111 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
67 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
122 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
252 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization until 199 deaths, up to November 2014, approximately 25 monthsPopulation: All randomized participants
OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.
Outcome measures
| Measure |
Nivolumab
n=135 Participants
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
|
Docetaxel
n=137 Participants
Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
|
|---|---|---|
|
Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint
|
9.23 months
Interval 7.33 to 13.27
|
6.01 months
Interval 5.13 to 7.33
|
PRIMARY outcome
Timeframe: Randomization to 18 months post-randomization, up to June 2015Population: All randomized participants
The overall survival rate is the probability that a participant will be alive at 6, 12, and 18 months following randomization. Overall survival was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.
Outcome measures
| Measure |
Nivolumab
n=135 Participants
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
|
Docetaxel
n=137 Participants
Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
|
|---|---|---|
|
Overall Survival (OS) Rate in All Randomized Participants
18 months
|
28.1 Percent probability of OS
Interval 20.8 to 35.8
|
12.5 Percent probability of OS
Interval 7.6 to 18.7
|
|
Overall Survival (OS) Rate in All Randomized Participants
6 months
|
63.7 Percent probability of OS
Interval 55.0 to 71.2
|
50.7 Percent probability of OS
Interval 42.1 to 58.8
|
|
Overall Survival (OS) Rate in All Randomized Participants
12 months
|
42.2 Percent probability of OS
Interval 33.8 to 50.4
|
24.3 Percent probability of OS
Interval 17.4 to 31.7
|
PRIMARY outcome
Timeframe: Randomization until 199 deaths, up to November 2014, approximately 25 monthsPopulation: All randomized participants
The number of participants who died from any cause was reported for each arm. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.
Outcome measures
| Measure |
Nivolumab
n=135 Participants
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
|
Docetaxel
n=137 Participants
Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
|
|---|---|---|
|
Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint
|
86 Participants
|
113 Participants
|
SECONDARY outcome
Timeframe: From the date of randomization up to the date of objectively documented progression, up to approximately 103 monthsPopulation: All randomized participants
ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). BOR was defined as the best investigator-assessed response designation, recorded between the date of randomization and the date of objectively documented progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or the date of subsequent anti-cancer therapy (excluding on-treatment palliative radiotherapy of non-target bone lesions or Central Nervous System (CNS) lesions), whichever occurred first. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CIs were computed using the Clopper and Pearson method.
Outcome measures
| Measure |
Nivolumab
n=135 Participants
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
|
Docetaxel
n=137 Participants
Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
|
|---|---|---|
|
Objective Response Rate (ORR) in All Randomized Participants
|
20.0 Percentage of participants
Interval 13.6 to 27.7
|
8.8 Percentage of participants
Interval 4.6 to 14.8
|
SECONDARY outcome
Timeframe: From the date of randomization to the date of the first confirmed response, up to approximately 12 monthsPopulation: All confirmed responders (participants demonstrating CR or PR)
Time to Response (TTR) for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.
Outcome measures
| Measure |
Nivolumab
n=27 Participants
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
|
Docetaxel
n=12 Participants
Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
|
|---|---|---|
|
Time To Response (TTR) in Months for All Confirmed Responders
|
2.23 Months
Interval 1.6 to 11.8
|
2.09 Months
Interval 1.8 to 9.5
|
SECONDARY outcome
Timeframe: From the date of first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurred first, up to approximately 94 monthsPopulation: All confirmed responders (participants demonstrating CR or PR)
DOR was defined as the time from the date of first confirmed response to the date of the first documented tumor progression (per RECIST v1.1), as determined by the investigator, or death due to any cause, whichever occurred first. DOR was evaluated only for confirmed responders (i.e. participants with confirmed CR or PR). CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. Participants who neither progressed nor died were censored on the date of their last evaluable tumor assessment.
Outcome measures
| Measure |
Nivolumab
n=27 Participants
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
|
Docetaxel
n=12 Participants
Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
|
|---|---|---|
|
Duration of Objective Response (DOR) in Months for All Confirmed Responders
|
24.51 Months
Interval 9.76 to 69.65
|
8.41 Months
Interval 3.58 to 14.03
|
SECONDARY outcome
Timeframe: From randomization to specified timepoints, up to 84 monthsPopulation: All randomized participants
PFSR was defined as the percentage of participants who did not experience disease progression or death from any cause at a given time point following randomization. Progression was assessed by investigators according to RECIST v1.1. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who started any subsequent anti-cancer therapy (including on-treatment palliative radiation therapy (RT) of non-target bone lesions or CNS lesions) without a prior reported progression were to be censored at the last evaluable tumor assessment prior to or on initiation of the subsequent anti-cancer therapy.
Outcome measures
| Measure |
Nivolumab
n=135 Participants
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
|
Docetaxel
n=137 Participants
Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
|
|---|---|---|
|
Progression Free Survival Rate (PFSR)
84 months
|
6.1 Percentage of participants
Interval 2.4 to 12.2
|
NA Percentage of participants
Median, lower and upper limit not reached due to insufficient number of events.
|
|
Progression Free Survival Rate (PFSR)
48 months
|
8.9 Percentage of participants
Interval 4.5 to 15.1
|
NA Percentage of participants
Median, lower and upper limit not reached due to insufficient number of events.
|
|
Progression Free Survival Rate (PFSR)
60 months
|
8.9 Percentage of participants
Interval 4.5 to 15.1
|
NA Percentage of participants
Median, lower and upper limit not reached due to insufficient number of events.
|
|
Progression Free Survival Rate (PFSR)
6 months
|
38.4 Percentage of participants
Interval 30.0 to 46.8
|
22.6 Percentage of participants
Interval 15.7 to 30.2
|
|
Progression Free Survival Rate (PFSR)
12 months
|
21.0 Percentage of participants
Interval 14.3 to 28.6
|
7.2 Percentage of participants
Interval 3.4 to 12.8
|
|
Progression Free Survival Rate (PFSR)
18 months
|
15.87 Percentage of participants
Interval 9.9 to 22.8
|
1.8 Percentage of participants
Interval 0.4 to 5.7
|
|
Progression Free Survival Rate (PFSR)
24 months
|
14.8 Percentage of participants
Interval 9.1 to 21.8
|
NA Percentage of participants
Median, lower and upper limit not reached due to insufficient number of events.
|
|
Progression Free Survival Rate (PFSR)
36 months
|
11.0 Percentage of participants
Interval 6.1 to 17.5
|
NA Percentage of participants
Median, lower and upper limit not reached due to insufficient number of events.
|
|
Progression Free Survival Rate (PFSR)
72 months
|
7.6 Percentage of participants
Interval 3.5 to 13.7
|
NA Percentage of participants
Median, lower and upper limit not reached due to insufficient number of events.
|
SECONDARY outcome
Timeframe: From randomization up to the first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurred first, up to approximately 103 monthsPopulation: All randomized participants
PFS was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator per RECIST v1.1 criteria, or death due to any cause. Participants underwent radiographic tumor assessments every 6 weeks (+/- 5 days) from week 9 (+/- 5 days) for the first year on treatment, then every 12 weeks after the first year on treatment until documented disease progression. The PFS curves were estimated using KM method. Two-sided 95% CI for median PFS were computed by Brookmeyer and Crowley method (using log-log transformation). Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who started any subsequent anti-cancer therapy (including on-treatment palliative RT of non-target bone lesions or CNS lesions) without a prior reported progression were to be censored at the last evaluable tumor assessment prior to or on initiation of the subsequent anti-cancer therapy.
Outcome measures
| Measure |
Nivolumab
n=135 Participants
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
|
Docetaxel
n=137 Participants
Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
|
|---|---|---|
|
Progression-Free Survival (PFS) Time in Months for All Randomized Participants
|
3.48 Months
Interval 2.14 to 5.06
|
2.83 Months
Interval 2.1 to 3.52
|
SECONDARY outcome
Timeframe: From randomization up to Week 12Population: All randomized participants
Disease-related symptom improvement rate by Week 12 was defined as the percentage of randomized participants who had a 10 point or greater decrease from baseline in average symptom burden index score at any time between randomization and Week 12. The participant portion of the Lung Cancer Symptom Scale (LCSS) consisted of 6 symptom-specific questions that addressed cough, dyspnea, fatigue, pain, hemoptysis, and anorexia, plus 3 summary items on symptom distress, interference with activity level, and global health-related Quality of Life (QoL). The scores range from 0 to 100, with 0 representing the best possible score and 100 being the worst possible score. The average symptom burden index score at each assessment was defined as the mean of the 6 symptom-specific questions of the LCSS. 95% CIs were computed using Clopper-Pearson Method.
Outcome measures
| Measure |
Nivolumab
n=135 Participants
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
|
Docetaxel
n=137 Participants
Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
|
|---|---|---|
|
Percentage of Participants Experiencing Disease-related Symptom Improvement by Week 12
|
18.5 percentage of participants
Interval 12.4 to 26.1
|
21.2 percentage of participants
Interval 14.7 to 29.0
|
SECONDARY outcome
Timeframe: From the date of randomization to the date of death from any cause, up to approximately 103 monthsPopulation: All randomized participants
OS was measured in months for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method.
Outcome measures
| Measure |
Nivolumab
n=135 Participants
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
|
Docetaxel
n=137 Participants
Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
|
|---|---|---|
|
Overall Survival (OS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants
PD-L1 expression >= 5%
|
9.95 Months
Interval 5.82 to 16.69
|
6.37 Months
Interval 4.5 to 9.03
|
|
Overall Survival (OS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants
PD-L1 not quantifiable at baseline
|
9.41 Months
Interval 7.1 to 25.2
|
5.06 Months
Interval 3.02 to 6.11
|
|
Overall Survival (OS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants
PD-L1 expression < 5%
|
8.54 Months
Interval 5.49 to 12.62
|
6.14 Months
Interval 5.13 to 8.28
|
SECONDARY outcome
Timeframe: From the date of randomization up to the date of objectively documented progression, up to approximately 103 monthsPopulation: All randomized participants
ORR was reported for all randomized participants grouped by their baseline PD-L1 expression level. ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CIs were computed using the Clopper and Pearson method.
Outcome measures
| Measure |
Nivolumab
n=135 Participants
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
|
Docetaxel
n=137 Participants
Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
|
|---|---|---|
|
Objective Response Rate (ORR) by Baseline PD-L1 Expression for All Randomized Participants
PD-L1 expression >= 5%
|
21.4 Percentage of participants
Interval 10.3 to 36.8
|
7.7 Percentage of participants
Interval 1.6 to 20.9
|
|
Objective Response Rate (ORR) by Baseline PD-L1 Expression for All Randomized Participants
PD-L1 expression < 5%
|
14.7 Percentage of participants
Interval 7.6 to 24.7
|
11.6 Percentage of participants
Interval 5.1 to 21.6
|
|
Objective Response Rate (ORR) by Baseline PD-L1 Expression for All Randomized Participants
PD-L1 not quantifiable at baseline
|
38.9 Percentage of participants
Interval 17.3 to 64.3
|
3.4 Percentage of participants
Interval 0.1 to 17.8
|
SECONDARY outcome
Timeframe: From the date of first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurred first, up to approximately 103 monthsPopulation: All randomized participants
PFS time was measured for all randomized participants grouped by their baseline PD-L1 expression levels. PFS was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator per RECIST v1.1 criteria, or death due to any cause. The PFS curves were estimated using KM method. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who started subsequent anti-cancer therapy (including on-treatment palliative radiotherapy of non-target bone lesions or CNS lesions) without a prior reported progression were censored at the last evaluable tumor assessment prior to subsequent anti-cancer therapy.
Outcome measures
| Measure |
Nivolumab
n=135 Participants
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
|
Docetaxel
n=137 Participants
Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
|
|---|---|---|
|
Progression Free Survival (PFS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants
PD-L1 expression >= 5%
|
5.06 Months
Interval 2.1 to 7.56
|
3.06 Months
Interval 1.94 to 4.63
|
|
Progression Free Survival (PFS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants
PD-L1 expression < 5%
|
2.23 Months
Interval 1.94 to 4.73
|
2.92 Months
Interval 2.07 to 3.58
|
|
Progression Free Survival (PFS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants
PD-L1 not quantifiable at baseline
|
5.39 Months
Interval 2.1 to 10.45
|
2.23 Months
Interval 2.04 to 4.4
|
POST_HOC outcome
Timeframe: From the date of first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurred first, up to approximately 103 monthsPopulation: All randomized participants
OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Survival follow-up analysis occurred at the end of the study.
Outcome measures
| Measure |
Nivolumab
n=135 Participants
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
|
Docetaxel
n=137 Participants
Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
|
|---|---|---|
|
Overall Survival (OS) Time in Months for All Randomized Participants - Extended Collection
|
9.23 Months
Interval 7.33 to 12.62
|
6.01 Months
Interval 5.13 to 7.33
|
POST_HOC outcome
Timeframe: From the date of randomization up to the specified timepoints, up to 84 monthsPopulation: All randomized participants
The overall survival rate is the probability that a participant will be alive at the specified timepoints following randomization. Overall survival was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.
Outcome measures
| Measure |
Nivolumab
n=135 Participants
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
|
Docetaxel
n=137 Participants
Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
|
|---|---|---|
|
Overall Survival (OS) Rate in All Randomized Participants - Extended Collection
48 months
|
13.1 Percent probability of OS
Interval 8.1 to 19.5
|
4.4 Percent probability of OS
Interval 1.8 to 8.8
|
|
Overall Survival (OS) Rate in All Randomized Participants - Extended Collection
6 months
|
63.7 Percent probability of OS
Interval 55.0 to 71.2
|
50.4 Percent probability of OS
Interval 41.7 to 58.4
|
|
Overall Survival (OS) Rate in All Randomized Participants - Extended Collection
12 months
|
42.2 Percent probability of OS
Interval 33.8 to 50.4
|
24.1 Percent probability of OS
Interval 17.3 to 31.5
|
|
Overall Survival (OS) Rate in All Randomized Participants - Extended Collection
18 months
|
28.1 Percent probability of OS
Interval 20.8 to 35.9
|
12.4 Percent probability of OS
Interval 7.6 to 18.5
|
|
Overall Survival (OS) Rate in All Randomized Participants - Extended Collection
24 months
|
23.0 Percent probability of OS
Interval 16.3 to 30.3
|
8.0 Percent probability of OS
Interval 4.3 to 13.3
|
|
Overall Survival (OS) Rate in All Randomized Participants - Extended Collection
36 months
|
15.6 Percent probability of OS
Interval 10.0 to 22.2
|
5.8 Percent probability of OS
Interval 2.7 to 10.6
|
|
Overall Survival (OS) Rate in All Randomized Participants - Extended Collection
60 months
|
12.3 Percent probability of OS
Interval 7.4 to 18.5
|
3.6 Percent probability of OS
Interval 1.4 to 7.8
|
|
Overall Survival (OS) Rate in All Randomized Participants - Extended Collection
72 months
|
11.4 Percent probability of OS
Interval 6.7 to 17.5
|
2.7 Percent probability of OS
Interval 0.8 to 6.7
|
|
Overall Survival (OS) Rate in All Randomized Participants - Extended Collection
84 months
|
9.6 Percent probability of OS
Interval 5.3 to 15.5
|
0.0 Percent probability of OS
Lower and upper limit not calculated due to insufficient number of events.
|
Adverse Events
Nivolumab 3 mg/kg
Serious events: 85 serious events
Other events: 120 other events
Deaths: 119 deaths
Nivolumab 480 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 2 deaths
Docetaxel
Serious events: 92 serious events
Other events: 123 other events
Deaths: 129 deaths
Extension Phase of Docetaxel Arm: Nivolumab 3 mg/kg
Serious events: 4 serious events
Other events: 4 other events
Deaths: 5 deaths
Extension Phase of Docetaxel Arm: Nivolumab 480 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Nivolumab 3 mg/kg
n=131 participants at risk
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
|
Nivolumab 480 mg
n=6 participants at risk
Nivolumab 480 mg solution intravenously every 4 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
|
Docetaxel
n=129 participants at risk
Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression , discontinuation due to toxicity, withdrawal of consent or study ends.
|
Extension Phase of Docetaxel Arm: Nivolumab 3 mg/kg
n=6 participants at risk
Eligible patients from the Docetaxel arm may receive nivolumab 3 mg/kg every 2 weeks via extension phase until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
|
Extension Phase of Docetaxel Arm: Nivolumab 480 mg
n=1 participants at risk
Eligible patients from the Docetaxel arm may receive nivolumab 480 mg flat dose every 4 weeks via extension phase until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
2/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
10.1%
13/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
2.3%
3/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
3.1%
4/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Cardiac disorders
Atrial thrombosis
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Cardiac disorders
Cardiac failure
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Cardiac disorders
Cardiac tamponade
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.5%
2/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
1.6%
2/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Cardiac disorders
Pericardial effusion
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Cardiac disorders
Sinus bradycardia
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Endocrine disorders
Goitre
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Endocrine disorders
Hypothyroidism
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
2.3%
3/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Gastrointestinal disorders
Dysphagia
|
2.3%
3/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Gastrointestinal disorders
Nausea
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Gastrointestinal disorders
Oesophagitis
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Gastrointestinal disorders
Pancreatitis
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
1.6%
2/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
General disorders
Asthenia
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
1.6%
2/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
General disorders
Chills
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
General disorders
Fatigue
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
General disorders
General physical health deterioration
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
General disorders
Oedema peripheral
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
General disorders
Pain
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
General disorders
Pyrexia
|
3.8%
5/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
General disorders
Sudden death
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
General disorders
Swelling
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Infections and infestations
Bronchitis
|
1.5%
2/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Infections and infestations
Infection
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Infections and infestations
Lower respiratory tract infection
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Infections and infestations
Neutropenic infection
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Infections and infestations
Pneumonia
|
10.7%
14/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
13.2%
17/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Infections and infestations
Respiratory tract infection
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Infections and infestations
Sepsis
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
2.3%
3/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Infections and infestations
Septic shock
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Infections and infestations
Skin infection
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Infections and infestations
Upper respiratory tract infection
|
1.5%
2/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Infections and infestations
Urinary tract infection
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Infections and infestations
Viral infection
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Injury, poisoning and procedural complications
Fall
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Investigations
Blood potassium decreased
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Investigations
C-reactive protein increased
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
2/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
2.3%
3/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.1%
4/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
30.5%
40/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
27.9%
36/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Nervous system disorders
Aphasia
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
1.6%
2/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Nervous system disorders
Dizziness
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Nervous system disorders
Ischaemic stroke
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Nervous system disorders
Myasthenic syndrome
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Nervous system disorders
Seizure
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Nervous system disorders
Spinal cord compression
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Nervous system disorders
Syncope
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Psychiatric disorders
Delirium
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Renal and urinary disorders
Haematuria
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.5%
2/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
4/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
3.1%
4/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
1.6%
2/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.5%
2/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.3%
3/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
1.6%
2/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
3.1%
4/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.3%
3/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
3.9%
5/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Vascular disorders
Peripheral ischaemia
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
Other adverse events
| Measure |
Nivolumab 3 mg/kg
n=131 participants at risk
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
|
Nivolumab 480 mg
n=6 participants at risk
Nivolumab 480 mg solution intravenously every 4 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
|
Docetaxel
n=129 participants at risk
Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression , discontinuation due to toxicity, withdrawal of consent or study ends.
|
Extension Phase of Docetaxel Arm: Nivolumab 3 mg/kg
n=6 participants at risk
Eligible patients from the Docetaxel arm may receive nivolumab 3 mg/kg every 2 weeks via extension phase until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
|
Extension Phase of Docetaxel Arm: Nivolumab 480 mg
n=1 participants at risk
Eligible patients from the Docetaxel arm may receive nivolumab 480 mg flat dose every 4 weeks via extension phase until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.6%
27/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
33.3%
43/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.3%
3/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
8.5%
11/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.1%
4/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
33.3%
43/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Endocrine disorders
Hypothyroidism
|
5.3%
7/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Gastrointestinal disorders
Abdominal pain
|
6.1%
8/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
7.8%
10/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Gastrointestinal disorders
Constipation
|
13.7%
18/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
14.7%
19/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Gastrointestinal disorders
Diarrhoea
|
18.3%
24/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
26.4%
34/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Gastrointestinal disorders
Nausea
|
18.3%
24/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
25.6%
33/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Gastrointestinal disorders
Vomiting
|
9.2%
12/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
14.7%
19/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
General disorders
Asthenia
|
19.1%
25/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
20.9%
27/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
General disorders
Chest pain
|
4.6%
6/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
7.8%
10/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
General disorders
Chills
|
6.9%
9/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
1.6%
2/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
General disorders
Fatigue
|
32.1%
42/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
40.3%
52/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
General disorders
Mucosal inflammation
|
2.3%
3/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
10.1%
13/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
General disorders
Non-cardiac chest pain
|
6.1%
8/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
1.6%
2/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
General disorders
Oedema peripheral
|
8.4%
11/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
12.4%
16/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
General disorders
Pain
|
6.1%
8/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
4.7%
6/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
General disorders
Pyrexia
|
20.6%
27/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
20.2%
26/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
50.0%
3/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Infections and infestations
Bronchitis
|
10.7%
14/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
3.1%
4/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Infections and infestations
Pneumonia
|
4.6%
6/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
5.4%
7/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
8/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
3.9%
5/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Infections and infestations
Urinary tract infection
|
3.1%
4/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
4.7%
6/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Investigations
Blood alkaline phosphatase increased
|
6.1%
8/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
2.3%
3/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
6.2%
8/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Investigations
Weight decreased
|
9.9%
13/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
6.2%
8/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Investigations
White blood cell count decreased
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
6.2%
8/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Metabolism and nutrition disorders
Decreased appetite
|
26.7%
35/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
31.8%
41/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.3%
7/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
1.6%
2/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.9%
9/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
7.8%
10/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.3%
7/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
3.1%
4/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.1%
8/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
3.9%
5/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.0%
17/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
14.7%
19/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.7%
14/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
9.3%
12/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.3%
3/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
5.4%
7/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.3%
7/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
2.3%
3/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.3%
3/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
11.6%
15/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Nervous system disorders
Dizziness
|
9.9%
13/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
10.1%
13/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Nervous system disorders
Headache
|
13.7%
18/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
7.8%
10/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Nervous system disorders
Neuropathy peripheral
|
3.1%
4/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
10.9%
14/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Nervous system disorders
Paraesthesia
|
3.8%
5/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
7.0%
9/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Psychiatric disorders
Insomnia
|
6.9%
9/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
5.4%
7/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
34.4%
45/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
18.6%
24/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
7.6%
10/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
35.9%
47/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
30.2%
39/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.9%
9/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
7.8%
10/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.3%
7/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
3.9%
5/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.5%
2/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
23.3%
30/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.4%
11/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
2.3%
3/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.2%
12/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
9.3%
12/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Vascular disorders
Hypotension
|
5.3%
7/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
3.9%
5/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Endocrine disorders
Cushing's syndrome
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Eye disorders
Blepharochalasis
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Eye disorders
Trichiasis
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Gastrointestinal disorders
Anal ulcer
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Gastrointestinal disorders
Dry mouth
|
2.3%
3/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
1.6%
2/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Gastrointestinal disorders
Dyspepsia
|
3.1%
4/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
3.1%
4/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
2.3%
3/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Gastrointestinal disorders
Oesophageal compression
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
General disorders
Generalised oedema
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
General disorders
Sensation of foreign body
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Infections and infestations
Nasopharyngitis
|
3.1%
4/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
4.7%
6/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Infections and infestations
Oral candidiasis
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
4.7%
6/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Infections and infestations
Paronychia
|
1.5%
2/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Infections and infestations
Pustule
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Infections and infestations
Respiratory tract infection
|
1.5%
2/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
3.1%
4/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Infections and infestations
Respiratory tract infection viral
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Investigations
Alanine aminotransferase increased
|
3.1%
4/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
2.3%
3/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Investigations
Aspartate aminotransferase increased
|
3.1%
4/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
2.3%
3/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Investigations
Blood creatinine increased
|
4.6%
6/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
1.6%
2/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Metabolism and nutrition disorders
Dehydration
|
4.6%
6/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
3.9%
5/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.1%
4/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
3.9%
5/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.5%
2/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.3%
3/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
2.3%
3/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.8%
5/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.8%
5/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
3.9%
5/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
2.3%
3/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.76%
1/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.78%
1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Skin and subcutaneous tissue disorders
Xanthelasma
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Vascular disorders
Hot flush
|
1.5%
2/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
2.3%
3/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Eye disorders
Visual impairment
|
3.1%
4/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
1.6%
2/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
General disorders
Malaise
|
1.5%
2/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
1.6%
2/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/131 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
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