Trial Outcomes & Findings for Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma (NCT NCT01721772)
NCT ID: NCT01721772
Last Updated: 2022-07-12
Results Overview
OS is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
418 participants
Primary outcome timeframe
From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed up to 17 months.
Results posted on
2022-07-12
Participant Flow
418 were randomized (210 to nivolumab, 208 to dacarbazine) and 411 received treatment (206 with nivolumab, 205 with dacarbazine).
Participant milestones
| Measure |
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine
Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
|
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab
Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
|
|---|---|---|
|
Pre-Treatment
STARTED
|
210
|
208
|
|
Pre-Treatment
COMPLETED
|
206
|
205
|
|
Pre-Treatment
NOT COMPLETED
|
4
|
3
|
|
Treatment
STARTED
|
206
|
205
|
|
Treatment
COMPLETED
|
0
|
0
|
|
Treatment
NOT COMPLETED
|
206
|
205
|
Reasons for withdrawal
| Measure |
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine
Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
|
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab
Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
|
|---|---|---|
|
Pre-Treatment
Participant no longer meets study criteria
|
3
|
1
|
|
Pre-Treatment
Poor/non-compliance
|
0
|
1
|
|
Pre-Treatment
Participant withdrew consent
|
0
|
1
|
|
Pre-Treatment
Adverse event unrelated to study drug
|
1
|
0
|
|
Treatment
Disease progression
|
119
|
168
|
|
Treatment
Study drug toxicity
|
19
|
10
|
|
Treatment
Adverse event unrelated to study drug
|
7
|
7
|
|
Treatment
Maximum clinical benefit
|
16
|
4
|
|
Treatment
Other
|
19
|
2
|
|
Treatment
Participant withdrew consent
|
2
|
5
|
|
Treatment
Participant request to discontinue study treatment
|
21
|
8
|
|
Treatment
Death
|
1
|
0
|
|
Treatment
Not reported
|
1
|
0
|
|
Treatment
Poor/non-compliance
|
1
|
0
|
|
Treatment
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine
n=210 Participants
Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
|
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab
n=208 Participants
Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
|
Total
n=418 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.6 Years
STANDARD_DEVIATION 13.00 • n=5 Participants
|
63.7 Years
STANDARD_DEVIATION 12.60 • n=7 Participants
|
62.7 Years
STANDARD_DEVIATION 12.83 • n=5 Participants
|
|
Age, Customized
Younger than 65 years
|
105 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
199 Participants
n=5 Participants
|
|
Age, Customized
65 to younger than 75 years
|
78 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Age, Customized
75 years and older
|
27 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
121 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
246 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
209 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
416 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed up to 17 months.Population: All randomized participants
OS is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive.
Outcome measures
| Measure |
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine
n=210 Participants
Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
|
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab
n=208 Participants
Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
|
|---|---|---|
|
Overall Survival (OS)
|
NA Months
NA due to insufficient number of events
|
10.84 Months
Interval 9.33 to 12.09
|
PRIMARY outcome
Timeframe: From randomization to 6 months and or to 12 monthsPopulation: All randomized participants
OS rate is calculated as the percentage of participants alive at the indicated timepoints
Outcome measures
| Measure |
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine
n=210 Participants
Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
|
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab
n=208 Participants
Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
|
|---|---|---|
|
Overall Survival (OS) Rate
At 6 months
|
84.1 Percentage of participants
Interval 78.3 to 88.5
|
71.8 Percentage of participants
Interval 64.9 to 77.6
|
|
Overall Survival (OS) Rate
At 12 months
|
72.9 Percentage of participants
Interval 65.5 to 78.9
|
42.1 Percentage of participants
Interval 33.0 to 50.9
|
SECONDARY outcome
Timeframe: From date of randomization up to date of disease progression or death, up to approximately 84 monthsPopulation: All randomized participants
Investigator-assessed PFS is defined as the time from randomization to the date of the first documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Patients who died without progressing were considered to have progressed on the date of their death. Those who did not progress or die were documented on the date of their last evaluable tumor assessment. Patients who did not have any on-study tumor assessments and did not die were documented on their date of randomization. Those who started any subsequent anticancer therapy without a prior reported progression were documented on the date of their last evaluable tumor assessment prior to initiation of subsequent anticancer therapy.
Outcome measures
| Measure |
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine
n=210 Participants
Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
|
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab
n=208 Participants
Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
|
|---|---|---|
|
Progression-free Survival (PFS)
|
5.06 Months
Interval 3.52 to 12.16
|
2.17 Months
Interval 2.1 to 2.5
|
SECONDARY outcome
Timeframe: From randomization to the specified timepoints, up to 84 monthsPopulation: All randomized participants
The PFS rate at a time point is the estimated percentage of patients who have not progressed and are alive at that time point following randomization and is estimated using the Kaplan-Meier methodology.
Outcome measures
| Measure |
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine
n=210 Participants
Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
|
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab
n=208 Participants
Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
|
|---|---|---|
|
Progression-free Survival (PFS) Rate
At 48 months
|
29.7 Percentage of participants
Interval 23.2 to 36.5
|
3.9 Percentage of participants
Interval 1.3 to 8.9
|
|
Progression-free Survival (PFS) Rate
At 60 months
|
28.4 Percentage of participants
Interval 22.0 to 35.2
|
3.9 Percentage of participants
Interval 1.3 to 8.9
|
|
Progression-free Survival (PFS) Rate
At 72 months
|
27.8 Percentage of participants
Interval 21.4 to 34.5
|
3.9 Percentage of participants
Interval 1.3 to 8.9
|
|
Progression-free Survival (PFS) Rate
At 6 months
|
48.2 Percentage of participants
Interval 41.0 to 55.0
|
20.0 Percentage of participants
Interval 14.6 to 26.1
|
|
Progression-free Survival (PFS) Rate
At 12 months
|
43.3 Percentage of participants
Interval 36.3 to 50.2
|
7.4 Percentage of participants
Interval 3.9 to 12.4
|
|
Progression-free Survival (PFS) Rate
At 18 months
|
40.5 Percentage of participants
Interval 33.5 to 47.4
|
5.2 Percentage of participants
Interval 2.2 to 10.2
|
|
Progression-free Survival (PFS) Rate
At 24 months
|
35.8 Percentage of participants
Interval 29.0 to 42.6
|
5.2 Percentage of participants
Interval 2.2 to 10.2
|
|
Progression-free Survival (PFS) Rate
At 36 months
|
32.8 Percentage of participants
Interval 26.1 to 39.6
|
3.9 Percentage of participants
Interval 1.3 to 8.9
|
|
Progression-free Survival (PFS) Rate
At 84 months
|
25.9 Percentage of participants
Interval 19.5 to 32.7
|
3.9 Percentage of participants
Interval 1.3 to 8.9
|
SECONDARY outcome
Timeframe: Tumor assessments beginning at 9 weeks following randomization and continuing every 6 weeks for the first year, then every 12 weeks thereafter until disease progression or death, assessed to 94 monthsPopulation: All randomized participants
ORR is defined as the percentage of participants with a best overall response of Response Evaluation Criteria in Solid Tumors (RECIST) defined complete response (CR) or partial response (PR). RECIST, volume 1.1 for target lesions: CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest dimension (LD) of target lesions, taking as reference the baseline sum LD; stable disease=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, and the sum LD must have an absolute increase of ≥5 mm.
Outcome measures
| Measure |
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine
n=210 Participants
Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
|
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab
n=208 Participants
Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
|
|---|---|---|
|
Objective Response Rate (ORR)
|
42.4 Percentage of participants
Interval 35.6 to 49.4
|
14.4 Percentage of participants
Interval 9.9 to 19.9
|
SECONDARY outcome
Timeframe: From date of randomization to date of disease progression or death, up to approximately 94 monthsPopulation: All randomized participants
Overall Survival is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive. PD-L1 expression level is defined as the percent of tumor cells demonstrating plasma membrane PD-L1-staining in a minimum of 100 evaluable tumor cells per a Dako PD-L1 IHC (immunohistochemistry) assay (referred to as quantifiable PD-L1 expression). Assessment of OS by PD-L1 expression as measured by a validated assay and comparing OS in patients with tumor PD-L1 expression ≥5% (PD-L1 positive) versus patients with tumor PD-L1 expression \<5% (PD-L1 negative). Tumor tissue samples for PD-L1 testing were collected at screening from metastatic or unresectable sites prior to randomization.
Outcome measures
| Measure |
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine
n=210 Participants
Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
|
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab
n=208 Participants
Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
|
|---|---|---|
|
Overall Survival by Programmed Cell Death Ligand 1 (PD-L1) Expression Level
PD-L1 positive participants (cutoff=5%)
|
53.36 Months
Interval 31.47 to
Upper limit not reached due to insufficient number of events
|
12.39 Months
Interval 9.33 to 18.99
|
|
Overall Survival by Programmed Cell Death Ligand 1 (PD-L1) Expression Level
PD-L1 negative/indeterminate participants (cutoff=5%)
|
26.97 Months
Interval 16.36 to 39.79
|
10.84 Months
Interval 8.38 to 12.25
|
SECONDARY outcome
Timeframe: At baseline and every 6 weeks for 12 months and at follow-up visits 1 and 2, assessed up to 93 monthsPopulation: All randomized participants with available measurements
HRQoL is evaluated by mean changes from baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) global health status/quality of life composite scale in all randomized patients. The QLQ-30 is a cancer-specific, self-administered questionnaire that contains 30 questions, covering global, functional, and symptom scales. Scores range from 0 to 100. Higher scores on global and functional scales indicate better quality of life (QoL), while higher scores on the symptom scales indicate declining QoL.
Outcome measures
| Measure |
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine
n=210 Participants
Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
|
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab
n=208 Participants
Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
|
|---|---|---|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 253
|
3.89 Units on a scale
Standard Deviation 26.89
|
16.67 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 259
|
7.05 Units on a scale
Standard Deviation 24.26
|
25.00 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 277
|
4.17 Units on a scale
Standard Deviation 21.12
|
25.00 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 283
|
5.56 Units on a scale
Standard Deviation 21.42
|
33.33 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 289
|
3.57 Units on a scale
Standard Deviation 20.86
|
33.33 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 301
|
2.78 Units on a scale
Standard Deviation 23.92
|
16.67 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 319
|
3.33 Units on a scale
Standard Deviation 26.70
|
33.33 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 325
|
9.38 Units on a scale
Standard Deviation 25.37
|
—
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 331
|
10.71 Units on a scale
Standard Deviation 27.09
|
33.33 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 337
|
11.90 Units on a scale
Standard Deviation 26.29
|
—
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 343
|
16.67 Units on a scale
Standard Deviation 26.35
|
—
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 349
|
9.52 Units on a scale
Standard Deviation 26.54
|
—
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 355
|
0 Units on a scale
Standard Deviation 10.21
|
—
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 361
|
20.83 Units on a scale
Standard Deviation 30.81
|
—
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 379
|
8.33 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
—
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 19
|
3.07 Units on a scale
Standard Deviation 16.58
|
3.15 Units on a scale
Standard Deviation 17.16
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 25
|
3.52 Units on a scale
Standard Deviation 20.25
|
-0.76 Units on a scale
Standard Deviation 21.28
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 31
|
2.53 Units on a scale
Standard Deviation 20.46
|
4.17 Units on a scale
Standard Deviation 17.83
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 37
|
3.26 Units on a scale
Standard Deviation 17.61
|
7.14 Units on a scale
Standard Deviation 18.45
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 7
|
1.39 Units on a scale
Standard Deviation 19.46
|
2.32 Units on a scale
Standard Deviation 20.52
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 13
|
1.49 Units on a scale
Standard Deviation 18.91
|
3.81 Units on a scale
Standard Deviation 16.33
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 49
|
4.31 Units on a scale
Standard Deviation 18.95
|
3.33 Units on a scale
Standard Deviation 13.94
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 55
|
2.92 Units on a scale
Standard Deviation 18.26
|
12.50 Units on a scale
Standard Deviation 23.42
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 61
|
1.79 Units on a scale
Standard Deviation 18.72
|
13.89 Units on a scale
Standard Deviation 17.35
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 67
|
2.08 Units on a scale
Standard Deviation 21.92
|
8.33 Units on a scale
Standard Deviation 11.79
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 85
|
3.05 Units on a scale
Standard Deviation 19.43
|
12.50 Units on a scale
Standard Deviation 5.89
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 91
|
3.66 Units on a scale
Standard Deviation 20.92
|
16.67 Units on a scale
Standard Deviation 0.00
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 97
|
4.27 Units on a scale
Standard Deviation 19.48
|
8.33 Units on a scale
Standard Deviation 11.79
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 103
|
6.20 Units on a scale
Standard Deviation 19.56
|
0.00 Units on a scale
Standard Deviation 0.00
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 109
|
3.83 Units on a scale
Standard Deviation 20.75
|
8.33 Units on a scale
Standard Deviation 11.79
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 115
|
4.17 Units on a scale
Standard Deviation 21.15
|
0.00 Units on a scale
Standard Deviation 0.00
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 121
|
1.47 Units on a scale
Standard Deviation 20.25
|
0.00 Units on a scale
Standard Deviation 0.00
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 127
|
-0.26 Units on a scale
Standard Deviation 19.91
|
—
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 133
|
3.16 Units on a scale
Standard Deviation 22.09
|
16.67 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 151
|
1.67 Units on a scale
Standard Deviation 20.34
|
16.67 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 157
|
3.53 Units on a scale
Standard Deviation 22.99
|
33.33 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 163
|
7.94 Units on a scale
Standard Deviation 20.83
|
16.67 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 169
|
13.33 Units on a scale
Standard Deviation 17.61
|
33.33 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 175
|
7.84 Units on a scale
Standard Deviation 23.66
|
50.00 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 181
|
5.42 Units on a scale
Standard Deviation 21.16
|
—
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 187
|
1.85 Units on a scale
Standard Deviation 22.06
|
33.33 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 397
|
8.33 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
—
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 403
|
8.33 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
—
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 43
|
1.69 Units on a scale
Standard Deviation 20.24
|
-1.04 Units on a scale
Standard Deviation 18.06
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 73
|
4.69 Units on a scale
Standard Deviation 17.10
|
12.50 Units on a scale
Standard Deviation 5.89
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 79
|
5.62 Units on a scale
Standard Deviation 18.84
|
8.33 Units on a scale
Standard Deviation 11.79
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 193
|
2.50 Units on a scale
Standard Deviation 20.96
|
16.67 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 139
|
1.11 Units on a scale
Standard Deviation 21.86
|
16.67 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 145
|
4.69 Units on a scale
Standard Deviation 20.07
|
16.67 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 199
|
6.77 Units on a scale
Standard Deviation 21.13
|
33.33 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 205
|
0.93 Units on a scale
Standard Deviation 24.07
|
33.33 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 211
|
0.49 Units on a scale
Standard Deviation 18.97
|
—
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 217
|
1.19 Units on a scale
Standard Deviation 23.32
|
33.33 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 223
|
5.26 Units on a scale
Standard Deviation 25.49
|
33.33 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 229
|
5.56 Units on a scale
Standard Deviation 23.77
|
16.67 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 235
|
5.39 Units on a scale
Standard Deviation 24.82
|
—
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 241
|
2.78 Units on a scale
Standard Deviation 25.72
|
—
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 247
|
5.36 Units on a scale
Standard Deviation 25.45
|
16.67 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 265
|
8.93 Units on a scale
Standard Deviation 21.55
|
33.33 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 271
|
6.25 Units on a scale
Standard Deviation 21.94
|
—
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 295
|
3.47 Units on a scale
Standard Deviation 23.15
|
16.67 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 307
|
1.52 Units on a scale
Standard Deviation 24.95
|
33.33 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 313
|
9.17 Units on a scale
Standard Deviation 24.04
|
—
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 367
|
25.00 Units on a scale
Standard Deviation 36.32
|
—
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 373
|
25.00 Units on a scale
Standard Deviation 36.32
|
—
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 385
|
8.33 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
—
|
|
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Week 391
|
8.33 Units on a scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation
|
—
|
POST_HOC outcome
Timeframe: From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed up to 94 months.Population: All randomized participants
OS is defined as the time between the date of randomization and the date of death. For those without documentation of death, OS will be censored on the last date the participant was known to be alive. OS data for this endpoint was collected after the primary completion date up until study completion.
Outcome measures
| Measure |
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine
n=210 Participants
Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
|
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab
n=208 Participants
Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
|
|---|---|---|
|
Overall Survival (OS) Extended
|
37.29 Months
Interval 25.4 to 51.55
|
11.17 Months
Interval 9.56 to 12.98
|
POST_HOC outcome
Timeframe: From randomization to the specified timepoints, up to 84 monthsPopulation: All randomized participants
OS rate is calculated as the percentage of participants alive at the indicated timepoints. Data for this endpoint was collected after the primary completion date up until study completion. The OS rate for the 6 month and 12 month timepoints reflect updated data that was collected after the primary completion date.
Outcome measures
| Measure |
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine
n=210 Participants
Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
|
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab
n=208 Participants
Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
|
|---|---|---|
|
Overall Survival (OS) Rate Extended
6 months
|
48.2 Percentage of participants
Interval 41.0 to 55.0
|
20.0 Percentage of participants
Interval 14.6 to 26.1
|
|
Overall Survival (OS) Rate Extended
12 months
|
43.3 Percentage of participants
Interval 36.3 to 50.2
|
7.4 Percentage of participants
Interval 3.9 to 12.4
|
|
Overall Survival (OS) Rate Extended
18 months
|
63.8 Percentage of participants
Interval 56.8 to 70.0
|
36.7 Percentage of participants
Interval 30.0 to 43.3
|
|
Overall Survival (OS) Rate Extended
24 months
|
57.8 Percentage of participants
Interval 50.7 to 64.2
|
26.3 Percentage of participants
Interval 20.4 to 32.6
|
|
Overall Survival (OS) Rate Extended
36 months
|
50.8 Percentage of participants
Interval 43.7 to 57.5
|
21.6 Percentage of participants
Interval 16.1 to 27.6
|
|
Overall Survival (OS) Rate Extended
48 months
|
43.8 Percentage of participants
Interval 36.9 to 50.5
|
17.9 Percentage of participants
Interval 12.9 to 23.6
|
|
Overall Survival (OS) Rate Extended
60 months
|
39.3 Percentage of participants
Interval 32.6 to 46.0
|
17.4 Percentage of participants
Interval 12.4 to 23.0
|
|
Overall Survival (OS) Rate Extended
72 months
|
37.3 Percentage of participants
Interval 30.7 to 43.9
|
16.9 Percentage of participants
Interval 12.0 to 22.5
|
|
Overall Survival (OS) Rate Extended
84 months
|
36.2 Percentage of participants
Interval 29.5 to 42.8
|
16.9 Percentage of participants
Interval 12.0 to 22.5
|
Adverse Events
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine
Serious events: 125 serious events
Other events: 191 other events
Deaths: 126 deaths
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab
Serious events: 119 serious events
Other events: 187 other events
Deaths: 165 deaths
Serious adverse events
| Measure |
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine
n=206 participants at risk
Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
|
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab
n=205 participants at risk
Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
|
|---|---|---|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Blood and lymphatic system disorders
Anaemia
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.98%
2/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.98%
2/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
2.0%
4/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
2.0%
4/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Cardiac disorders
Atrial fibrillation
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Cardiac disorders
Atrial flutter
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Cardiac disorders
Cardiac failure
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Ear and labyrinth disorders
Vertigo
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Endocrine disorders
Hypophysitis
|
0.97%
2/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Endocrine disorders
Hypopituitarism
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Endocrine disorders
Hypothyroidism
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Eye disorders
Diplopia
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Eye disorders
Eyelid retraction
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Eye disorders
Retinal vein thrombosis
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Eye disorders
Uveitis
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.98%
2/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Abdominal distension
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Abdominal pain
|
0.97%
2/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
2.0%
4/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Ascites
|
1.5%
3/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Colitis
|
1.9%
4/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Constipation
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
6/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
2.0%
4/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.98%
2/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Gastric mucosal lesion
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Pancreatitis
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Vomiting
|
0.97%
2/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.98%
2/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Chills
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Death
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Fatigue
|
0.97%
2/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
1.5%
3/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
General physical health deterioration
|
2.9%
6/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
2.9%
6/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Infusion site reaction
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Injection site reaction
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Oedema peripheral
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Pain
|
0.97%
2/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
2.9%
6/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Pyrexia
|
1.9%
4/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.98%
2/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Hepatitis
|
1.5%
3/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Jaundice
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Immune system disorders
Hypersensitivity
|
0.97%
2/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Bronchopulmonary aspergillosis allergic
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Cellulitis
|
1.5%
3/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.98%
2/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Coronavirus infection
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Erysipelas
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.98%
2/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Infected cyst
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Infection
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Infusion site infection
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Lower respiratory tract infection
|
0.97%
2/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Pneumonia
|
0.97%
2/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Pyelonephritis
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Sepsis
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Skin infection
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Urinary tract infection
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.98%
2/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.97%
2/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Post procedural inflammation
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Blood calcium decreased
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
General physical condition abnormal
|
0.97%
2/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Pancreatic enzymes abnormal
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.97%
2/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.97%
2/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.97%
2/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.98%
2/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.98%
2/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.97%
2/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.97%
2/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
3.9%
8/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal adenocarcinoma
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.97%
2/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
15.5%
32/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
33.7%
69/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma recurrent
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
1.5%
3/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.97%
2/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.97%
2/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
1.5%
3/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nodular melanoma
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin neoplasm bleeding
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.98%
2/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Dizziness
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Epilepsy
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Facial paresis
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Ischaemic stroke
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Nerve compression
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Neurological decompensation
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Presyncope
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Seizure
|
0.97%
2/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.98%
2/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Somnolence
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Spinal cord compression
|
0.97%
2/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.98%
2/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Transient ischaemic attack
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Product Issues
Device dislocation
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Product Issues
Device occlusion
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Psychiatric disorders
Confusional state
|
0.97%
2/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
2.0%
4/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Psychiatric disorders
Disorientation
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Psychiatric disorders
Mania
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Psychiatric disorders
Psychotic disorder
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Renal and urinary disorders
Acute kidney injury
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.98%
2/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Renal and urinary disorders
Haematuria
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Renal and urinary disorders
Renal injury
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Reproductive system and breast disorders
Endometriosis
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
4/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
3.4%
7/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.97%
2/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
3.4%
7/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.98%
2/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.97%
2/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Skin and subcutaneous tissue disorders
Sarcoid-like reaction
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Embolism
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Haematoma
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Haemorrhage
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Hypertension
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Hypotension
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Thrombosis
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
Other adverse events
| Measure |
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine
n=206 participants at risk
Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
|
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab
n=205 participants at risk
Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
12.6%
26/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
11.7%
24/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.49%
1/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
12.7%
26/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.97%
2/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
10.7%
22/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Endocrine disorders
Hyperthyroidism
|
5.3%
11/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
1.5%
3/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Endocrine disorders
Hypothyroidism
|
9.7%
20/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
3.9%
8/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Abdominal pain
|
14.6%
30/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
10.2%
21/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
17/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
5.9%
12/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Constipation
|
27.7%
57/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
27.8%
57/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Diarrhoea
|
36.4%
75/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
28.3%
58/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
11/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
3.4%
7/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Nausea
|
28.6%
59/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
50.7%
104/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Vomiting
|
16.5%
34/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
26.3%
54/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Asthenia
|
20.9%
43/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
18.5%
38/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Fatigue
|
37.4%
77/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
29.3%
60/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Influenza like illness
|
6.3%
13/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
2.0%
4/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Oedema peripheral
|
12.6%
26/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
5.4%
11/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Pain
|
6.3%
13/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
6.3%
13/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Pyrexia
|
17.5%
36/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
14.1%
29/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Bronchitis
|
5.8%
12/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
2.0%
4/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Influenza
|
7.3%
15/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
1.5%
3/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Nasopharyngitis
|
16.5%
34/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
4.9%
10/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Rhinitis
|
5.8%
12/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
1.5%
3/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Upper respiratory tract infection
|
9.7%
20/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
6.3%
13/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Urinary tract infection
|
6.3%
13/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
5.4%
11/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
17/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
3.4%
7/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Aspartate aminotransferase increased
|
5.8%
12/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
3.9%
8/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Blood alkaline phosphatase increased
|
5.8%
12/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
3.4%
7/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Blood creatinine increased
|
5.8%
12/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
2.9%
6/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.3%
13/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
2.9%
6/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Platelet count decreased
|
0.00%
0/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
5.4%
11/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Decreased appetite
|
19.4%
40/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
18.0%
37/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.8%
14/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.3%
46/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
14.1%
29/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.9%
39/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
11.2%
23/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.7%
18/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
6.3%
13/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.5%
34/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
9.8%
20/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Dizziness
|
6.8%
14/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
7.3%
15/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Headache
|
21.8%
45/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
15.6%
32/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Psychiatric disorders
Anxiety
|
7.8%
16/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
5.9%
12/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Psychiatric disorders
Insomnia
|
7.3%
15/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
4.4%
9/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.4%
40/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
14.1%
29/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.1%
25/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
12.2%
25/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.3%
11/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
2.0%
4/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
6.8%
14/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
0.49%
1/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.2%
21/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
2.4%
5/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Skin and subcutaneous tissue disorders
Erythema
|
14.1%
29/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
3.4%
7/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
2.4%
5/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
5.9%
12/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
31.1%
64/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
19.5%
40/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.6%
63/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
14.1%
29/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
18.0%
37/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
1.5%
3/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Hypertension
|
10.7%
22/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
2.4%
5/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Hypotension
|
2.4%
5/206 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
5.4%
11/205 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
|
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