Trial Outcomes & Findings for A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor (TKI) Therapy (NCT NCT02864251)
NCT ID: NCT02864251
Last Updated: 2023-09-28
Results Overview
PFS is defined as the time between the date of randomization and the date of first documented tumor progression, as determined by BICR (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Participants who died without reported progression will be considered to have progressed on the date of their death. Subsequent therapy was accounted for by censoring at the last evaluable tumor assessment on or prior to the date of subsequent therapy. Progression is the appearance of one or more new lesions. RECIST - "response evaluation criteria in solid tumors" is a standard system to measure tumor response to treatment. Based on Kaplan-Meier estimates
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
367 participants
Primary outcome timeframe
From randomization to the date of first documented tumor progression or death (approximately 58 months)
Results posted on
2023-09-28
Participant Flow
Arm B: Nivolumab plus Ipilimumab was exploratory and closed prior to primary completion.
Participant milestones
| Measure |
Arm A: Nivolumab Plus Platinum-doublet Chemotherapy
Nivolumab was administered IV every 3 weeks with platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) IV for a maximum of 4 cycles.
Treatment administered was either Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.
Following completion of the fourth cycle of nivolumab/chemotherapy, all participants who did not experience disease progression should have continued nivolumab 360 mg IV and pemetrexed (500 mg/m2) every 3 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, or study closure, whichever comes first. Nivolumab should only be administered for a maximum of 24 months (96 weeks) from the first study treatment.
|
Arm B: Nivolumab Plus Ipilimumab
Nivolumab 3 mg/kg IV was administered every 2 weeks and ipilimumab 1 mg/kg IV was administered every 6 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, a maximum of 24 months (96 weeks) from the first study treatment, or study closure.
|
Arm C: Platinum Doublet Chemotherapy
Platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) was administered IV in 3-week cycles for up to a maximum of 4 cycles.
Participants received either Pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.
Platinum-doublet chemotherapy continued until disease progression, unacceptable toxicity, or completion of the 4 cycles, whichever came first.
Participants who had stable disease or response after 4 cycles of pemetrexed with cisplatin or carboplatin should have continued pemetrexed alone as maintenance therapy until disease progression, or unacceptable toxicity.
|
|---|---|---|---|
|
Pre-Treatment
STARTED
|
144
|
73
|
150
|
|
Pre-Treatment
COMPLETED
|
141
|
71
|
143
|
|
Pre-Treatment
NOT COMPLETED
|
3
|
2
|
7
|
|
Treatment
STARTED
|
141
|
71
|
143
|
|
Treatment
COMPLETED
|
3
|
5
|
0
|
|
Treatment
NOT COMPLETED
|
138
|
66
|
143
|
Reasons for withdrawal
| Measure |
Arm A: Nivolumab Plus Platinum-doublet Chemotherapy
Nivolumab was administered IV every 3 weeks with platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) IV for a maximum of 4 cycles.
Treatment administered was either Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.
Following completion of the fourth cycle of nivolumab/chemotherapy, all participants who did not experience disease progression should have continued nivolumab 360 mg IV and pemetrexed (500 mg/m2) every 3 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, or study closure, whichever comes first. Nivolumab should only be administered for a maximum of 24 months (96 weeks) from the first study treatment.
|
Arm B: Nivolumab Plus Ipilimumab
Nivolumab 3 mg/kg IV was administered every 2 weeks and ipilimumab 1 mg/kg IV was administered every 6 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, a maximum of 24 months (96 weeks) from the first study treatment, or study closure.
|
Arm C: Platinum Doublet Chemotherapy
Platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) was administered IV in 3-week cycles for up to a maximum of 4 cycles.
Participants received either Pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.
Platinum-doublet chemotherapy continued until disease progression, unacceptable toxicity, or completion of the 4 cycles, whichever came first.
Participants who had stable disease or response after 4 cycles of pemetrexed with cisplatin or carboplatin should have continued pemetrexed alone as maintenance therapy until disease progression, or unacceptable toxicity.
|
|---|---|---|---|
|
Pre-Treatment
Adverse Event Unrelated to Study drug
|
1
|
0
|
0
|
|
Pre-Treatment
Withdrawal by Participant
|
0
|
0
|
4
|
|
Pre-Treatment
Participant no Longer Meets Study Criteria
|
2
|
1
|
2
|
|
Pre-Treatment
Other Reasons
|
0
|
1
|
1
|
|
Treatment
Disease Progression
|
109
|
52
|
101
|
|
Treatment
Study Drug Toxicity
|
9
|
4
|
10
|
|
Treatment
Death
|
0
|
2
|
3
|
|
Treatment
Adverse Event Unrelated to Study Drug
|
1
|
1
|
6
|
|
Treatment
Participant Requested to Discontinue Study Treatment
|
8
|
0
|
5
|
|
Treatment
Withdrawal by Participant
|
8
|
5
|
13
|
|
Treatment
Maximum Clinical Benefit
|
1
|
0
|
1
|
|
Treatment
Participant no Longer Meets Study Criteria
|
0
|
1
|
0
|
|
Treatment
Other Reasons
|
1
|
1
|
4
|
|
Treatment
Administrative Reason by Sponsor
|
1
|
0
|
0
|
Baseline Characteristics
A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor (TKI) Therapy
Baseline characteristics by cohort
| Measure |
Arm A: Nivolumab Plus Platinum-doublet Chemotherapy
n=144 Participants
Nivolumab was administered IV every 3 weeks with platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) IV for a maximum of 4 cycles.
Treatment administered was either Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.
Following completion of the fourth cycle of nivolumab/chemotherapy, all participants who did not experience disease progression should have continued nivolumab 360 mg IV and pemetrexed (500 mg/m2) every 3 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, or study closure, whichever comes first. Nivolumab should only be administered for a maximum of 24 months (96 weeks) from the first study treatment.
|
Arm B: Nivolumab Plus Ipilimumab
n=73 Participants
Nivolumab 3 mg/kg IV was administered every 2 weeks and ipilimumab 1 mg/kg IV was administered every 6 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, a maximum of 24 months (96 weeks) from the first study treatment, or study closure.
|
Arm C: Platinum Doublet Chemotherapy
n=150 Participants
Platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) was administered IV in 3-week cycles for up to a maximum of 4 cycles.
Participants received either Pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.
Platinum-doublet chemotherapy continued until disease progression, unacceptable toxicity, or completion of the 4 cycles, whichever came first.
Participants who had stable disease or response after 4 cycles of pemetrexed with cisplatin or carboplatin should have continued pemetrexed alone as maintenance therapy until disease progression, or unacceptable toxicity.
|
Total
n=367 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.3 Years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
61.9 Years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
60.7 Years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
61.6 Years
STANDARD_DEVIATION 10.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
214 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
153 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
171 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
85 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
196 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
136 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
343 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From randomization to the date of first documented tumor progression or death (approximately 58 months)Population: All randomized participants
PFS is defined as the time between the date of randomization and the date of first documented tumor progression, as determined by BICR (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Participants who died without reported progression will be considered to have progressed on the date of their death. Subsequent therapy was accounted for by censoring at the last evaluable tumor assessment on or prior to the date of subsequent therapy. Progression is the appearance of one or more new lesions. RECIST - "response evaluation criteria in solid tumors" is a standard system to measure tumor response to treatment. Based on Kaplan-Meier estimates
Outcome measures
| Measure |
Arm A: Nivolumab Plus Platinum-doublet Chemotherapy
n=144 Participants
Nivolumab was administered IV every 3 weeks with platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) IV for a maximum of 4 cycles.
Treatment administered was either Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.
Following completion of the fourth cycle of nivolumab/chemotherapy, all participants who did not experience disease progression should have continued nivolumab 360 mg IV and pemetrexed (500 mg/m2) every 3 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, or study closure, whichever comes first. Nivolumab should only be administered for a maximum of 24 months (96 weeks) from the first study treatment.
|
Arm B: Nivolumab Plus Ipilimumab
n=73 Participants
Nivolumab 3 mg/kg IV was administered every 2 weeks and ipilimumab 1 mg/kg IV was administered every 6 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, a maximum of 24 months (96 weeks) from the first study treatment, or study closure.
|
Arm C: Platinum Doublet Chemotherapy
n=150 Participants
Platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) was administered IV in 3-week cycles for up to a maximum of 4 cycles.
Participants received either Pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.
Platinum-doublet chemotherapy continued until disease progression, unacceptable toxicity, or completion of the 4 cycles, whichever came first.
Participants who had stable disease or response after 4 cycles of pemetrexed with cisplatin or carboplatin should have continued pemetrexed alone as maintenance therapy until disease progression, or unacceptable toxicity.
|
|---|---|---|---|
|
Progression Free Survival (PFS) by Blinded Independent Centralized Review (BICR)
|
5.59 Months
Interval 4.47 to 6.8
|
1.54 Months
Interval 1.41 to 2.63
|
5.45 Months
Interval 4.4 to 5.65
|
SECONDARY outcome
Timeframe: From randomization to the date of death due to any cause (up to approximately 67 months)Population: All randomized participants
Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a participant was known to be alive. Median based on Kaplan-Meier Estimates
Outcome measures
| Measure |
Arm A: Nivolumab Plus Platinum-doublet Chemotherapy
n=144 Participants
Nivolumab was administered IV every 3 weeks with platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) IV for a maximum of 4 cycles.
Treatment administered was either Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.
Following completion of the fourth cycle of nivolumab/chemotherapy, all participants who did not experience disease progression should have continued nivolumab 360 mg IV and pemetrexed (500 mg/m2) every 3 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, or study closure, whichever comes first. Nivolumab should only be administered for a maximum of 24 months (96 weeks) from the first study treatment.
|
Arm B: Nivolumab Plus Ipilimumab
n=73 Participants
Nivolumab 3 mg/kg IV was administered every 2 weeks and ipilimumab 1 mg/kg IV was administered every 6 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, a maximum of 24 months (96 weeks) from the first study treatment, or study closure.
|
Arm C: Platinum Doublet Chemotherapy
n=150 Participants
Platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) was administered IV in 3-week cycles for up to a maximum of 4 cycles.
Participants received either Pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.
Platinum-doublet chemotherapy continued until disease progression, unacceptable toxicity, or completion of the 4 cycles, whichever came first.
Participants who had stable disease or response after 4 cycles of pemetrexed with cisplatin or carboplatin should have continued pemetrexed alone as maintenance therapy until disease progression, or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Survival (OS)
|
19.35 Months
Interval 16.13 to 20.99
|
17.12 Months
Interval 13.67 to 23.59
|
15.90 Months
Interval 14.0 to 18.79
|
SECONDARY outcome
Timeframe: From randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (up to approximately 67 months)Population: All randomized participants
ORR is number of randomized participants who have confirmed best overall response (BOR) of complete response (CR) or partial response (PR) using RECIST v1.1 criteria by BICR assessment. BOR is the best response designation, between randomization and objectively documented progression per RECIST v1.1 criteria by BICR or the date of subsequent anti-cancer therapy, whichever occurs first. PR is at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as reference. CR is disappearance of all target lesions and a reduction in the short axis of pathological lymph nodes to \<10 mm (whether target or non-target). Radiographic tumor response assessments from Week 7 (± 7 days), then every 6 weeks (± 7 days) until Week 49 and every 12 weeks (± 7 days) thereafter, until disease progression, treatment discontinued, or the start of subsequent anti-cancer therapy. CR+PR, confidence interval based on the Clopper and Pearson method.
Outcome measures
| Measure |
Arm A: Nivolumab Plus Platinum-doublet Chemotherapy
n=144 Participants
Nivolumab was administered IV every 3 weeks with platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) IV for a maximum of 4 cycles.
Treatment administered was either Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.
Following completion of the fourth cycle of nivolumab/chemotherapy, all participants who did not experience disease progression should have continued nivolumab 360 mg IV and pemetrexed (500 mg/m2) every 3 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, or study closure, whichever comes first. Nivolumab should only be administered for a maximum of 24 months (96 weeks) from the first study treatment.
|
Arm B: Nivolumab Plus Ipilimumab
n=73 Participants
Nivolumab 3 mg/kg IV was administered every 2 weeks and ipilimumab 1 mg/kg IV was administered every 6 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, a maximum of 24 months (96 weeks) from the first study treatment, or study closure.
|
Arm C: Platinum Doublet Chemotherapy
n=150 Participants
Platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) was administered IV in 3-week cycles for up to a maximum of 4 cycles.
Participants received either Pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.
Platinum-doublet chemotherapy continued until disease progression, unacceptable toxicity, or completion of the 4 cycles, whichever came first.
Participants who had stable disease or response after 4 cycles of pemetrexed with cisplatin or carboplatin should have continued pemetrexed alone as maintenance therapy until disease progression, or unacceptable toxicity.
|
|---|---|---|---|
|
Objective Response Rate (ORR) by Blinded Independent Centralized Review (BICR)
|
30.6 Percent of Participants
Interval 23.2 to 38.8
|
13.7 Percent of Participants
Interval 6.8 to 23.8
|
26.7 Percent of Participants
Interval 19.8 to 34.5
|
SECONDARY outcome
Timeframe: From randomization to the date of first documented disease progression or death due to any cause (approximately 67 months)Population: Randomized participants with CR or PR
DOR is the time between the date of first response (CR or PR) and the date of first documented disease progression as determined by Response Evaluation Criteria In Solid Tumors (RECIST 1.1) or death due to any cause (death occurring after re-treatment or randomization to new combination treatment was not included), whichever occurred first. PR is at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as reference. CR is disappearance of all target lesions and a reduction in the short axis of pathological lymph nodes to \<10 mm (whether target or non-target). Radiographic tumor response assessments from Week 7 (± 7 days), then every 6 weeks (± 7 days) until Week 49 and every 12 weeks (± 7 days) thereafter, until disease progression, treatment discontinued, or the start of subsequent anti-cancer therapy. Participants who neither progress nor die were censored on the date of their last assessment. Median computed using Kaplan-Meier method
Outcome measures
| Measure |
Arm A: Nivolumab Plus Platinum-doublet Chemotherapy
n=44 Participants
Nivolumab was administered IV every 3 weeks with platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) IV for a maximum of 4 cycles.
Treatment administered was either Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.
Following completion of the fourth cycle of nivolumab/chemotherapy, all participants who did not experience disease progression should have continued nivolumab 360 mg IV and pemetrexed (500 mg/m2) every 3 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, or study closure, whichever comes first. Nivolumab should only be administered for a maximum of 24 months (96 weeks) from the first study treatment.
|
Arm B: Nivolumab Plus Ipilimumab
n=10 Participants
Nivolumab 3 mg/kg IV was administered every 2 weeks and ipilimumab 1 mg/kg IV was administered every 6 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, a maximum of 24 months (96 weeks) from the first study treatment, or study closure.
|
Arm C: Platinum Doublet Chemotherapy
n=40 Participants
Platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) was administered IV in 3-week cycles for up to a maximum of 4 cycles.
Participants received either Pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.
Platinum-doublet chemotherapy continued until disease progression, unacceptable toxicity, or completion of the 4 cycles, whichever came first.
Participants who had stable disease or response after 4 cycles of pemetrexed with cisplatin or carboplatin should have continued pemetrexed alone as maintenance therapy until disease progression, or unacceptable toxicity.
|
|---|---|---|---|
|
Duration of Response (DOR) by Blinded Independent Centralized Review (BICR)
|
6.67 Months
Interval 4.17 to 12.45
|
50.04 Months
Interval 2.86 to
Insufficient number of participants with events
|
5.55 Months
Interval 4.07 to 9.92
|
SECONDARY outcome
Timeframe: 9 months after first treatment dosePopulation: All randomized participants
The PFSR at 9 months is defined as the percent of treated participants remaining progression free and surviving at 9 months since the first dosing date. Progression is the appearance of one or more new lesions. Point estimates are derived from Kaplan-Meier analyses.
Outcome measures
| Measure |
Arm A: Nivolumab Plus Platinum-doublet Chemotherapy
n=144 Participants
Nivolumab was administered IV every 3 weeks with platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) IV for a maximum of 4 cycles.
Treatment administered was either Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.
Following completion of the fourth cycle of nivolumab/chemotherapy, all participants who did not experience disease progression should have continued nivolumab 360 mg IV and pemetrexed (500 mg/m2) every 3 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, or study closure, whichever comes first. Nivolumab should only be administered for a maximum of 24 months (96 weeks) from the first study treatment.
|
Arm B: Nivolumab Plus Ipilimumab
n=73 Participants
Nivolumab 3 mg/kg IV was administered every 2 weeks and ipilimumab 1 mg/kg IV was administered every 6 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, a maximum of 24 months (96 weeks) from the first study treatment, or study closure.
|
Arm C: Platinum Doublet Chemotherapy
n=150 Participants
Platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) was administered IV in 3-week cycles for up to a maximum of 4 cycles.
Participants received either Pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.
Platinum-doublet chemotherapy continued until disease progression, unacceptable toxicity, or completion of the 4 cycles, whichever came first.
Participants who had stable disease or response after 4 cycles of pemetrexed with cisplatin or carboplatin should have continued pemetrexed alone as maintenance therapy until disease progression, or unacceptable toxicity.
|
|---|---|---|---|
|
9 Month Progression Free Survival Rates (PFSR) by Blinded Independent Centralized Review (BICR)
|
25.9 Percent of Participants
Interval 18.4 to 34.0
|
12.2 Percent of Participants
Interval 5.5 to 21.7
|
19.8 Percent of Participants
Interval 12.6 to 28.1
|
SECONDARY outcome
Timeframe: 12 Months after first treatment dosePopulation: All randomized participants
The PFSR at 12 months is defined as the percent of treated participants remaining progression free and surviving at 12 months since the first dosing date. Progression is the appearance of one or more new lesions. Point estimates are derived from Kaplan-Meier analyses.
Outcome measures
| Measure |
Arm A: Nivolumab Plus Platinum-doublet Chemotherapy
n=144 Participants
Nivolumab was administered IV every 3 weeks with platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) IV for a maximum of 4 cycles.
Treatment administered was either Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.
Following completion of the fourth cycle of nivolumab/chemotherapy, all participants who did not experience disease progression should have continued nivolumab 360 mg IV and pemetrexed (500 mg/m2) every 3 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, or study closure, whichever comes first. Nivolumab should only be administered for a maximum of 24 months (96 weeks) from the first study treatment.
|
Arm B: Nivolumab Plus Ipilimumab
n=73 Participants
Nivolumab 3 mg/kg IV was administered every 2 weeks and ipilimumab 1 mg/kg IV was administered every 6 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, a maximum of 24 months (96 weeks) from the first study treatment, or study closure.
|
Arm C: Platinum Doublet Chemotherapy
n=150 Participants
Platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) was administered IV in 3-week cycles for up to a maximum of 4 cycles.
Participants received either Pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.
Platinum-doublet chemotherapy continued until disease progression, unacceptable toxicity, or completion of the 4 cycles, whichever came first.
Participants who had stable disease or response after 4 cycles of pemetrexed with cisplatin or carboplatin should have continued pemetrexed alone as maintenance therapy until disease progression, or unacceptable toxicity.
|
|---|---|---|---|
|
12 Month Progression Free Survival Rates (PFSR) by Blinded Independent Centralized Review (BICR)
|
21.2 Percent of Participants
Interval 14.3 to 29.1
|
12.2 Percent of Participants
Interval 5.5 to 21.7
|
15.9 Percent of Participants
Interval 9.3 to 24.0
|
Adverse Events
Arm A: Nivolumab Plus Platinum-doublet Chemotherapy
Serious events: 77 serious events
Other events: 136 other events
Deaths: 92 deaths
Arm B: Nivolumab Plus Ipilimumab
Serious events: 46 serious events
Other events: 62 other events
Deaths: 55 deaths
Arm C: Platinum Doublet Chemotherapy
Serious events: 55 serious events
Other events: 140 other events
Deaths: 105 deaths
Serious adverse events
| Measure |
Arm A: Nivolumab Plus Platinum-doublet Chemotherapy
n=141 participants at risk
Nivolumab was administered IV every 3 weeks with platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) IV for a maximum of 4 cycles.
Treatment administered was either Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.
Following completion of the fourth cycle of nivolumab/chemotherapy, all participants who did not experience disease progression should have continued nivolumab 360 mg IV and pemetrexed (500 mg/m2) every 3 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, or study closure, whichever comes first. Nivolumab should only be administered for a maximum of 24 months (96 weeks) from the first study treatment.
|
Arm B: Nivolumab Plus Ipilimumab
n=71 participants at risk
Nivolumab 3 mg/kg IV was administered every 2 weeks and ipilimumab 1 mg/kg IV was administered every 6 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, a maximum of 24 months (96 weeks) from the first study treatment, or study closure.
|
Arm C: Platinum Doublet Chemotherapy
n=143 participants at risk
Platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) was administered IV in 3-week cycles for up to a maximum of 4 cycles.
Participants received either Pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.
Platinum-doublet chemotherapy continued until disease progression, unacceptable toxicity, or completion of the 4 cycles, whichever came first.
Participants who had stable disease or response after 4 cycles of pemetrexed with cisplatin or carboplatin should have continued pemetrexed alone as maintenance therapy until disease progression, or unacceptable toxicity.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
7.1%
10/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
5.6%
4/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
4.9%
7/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
2.1%
3/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.4%
2/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Cardiac disorders
Atrial fibrillation
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Cardiac disorders
Immune-mediated myocarditis
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
2.8%
2/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Cardiac disorders
Sinus bradycardia
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Endocrine disorders
Thyroiditis subacute
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Eye disorders
Cataract
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Gastrointestinal disorders
Colitis
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
2.8%
2/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
2.8%
2/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Gastrointestinal disorders
Enteritis
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Gastrointestinal disorders
Nausea
|
2.1%
3/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
4/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
2.8%
2/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
General disorders
Asthenia
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
General disorders
Catheter site oedema
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
General disorders
Fatigue
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
General disorders
Pain
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
General disorders
Pyrexia
|
2.1%
3/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
2.8%
2/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
General disorders
Sudden death
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
General disorders
Swelling
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
2.1%
3/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
2.8%
2/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Infections and infestations
Breast cellulitis
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Infections and infestations
Carbuncle
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Infections and infestations
Cellulitis
|
2.1%
3/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Infections and infestations
Device related infection
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Infections and infestations
Gastroenteritis viral
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Infections and infestations
Herpes zoster
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Infections and infestations
Infection
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Infections and infestations
Influenza
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
2.8%
2/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Infections and infestations
Meningitis
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Infections and infestations
Pneumonia aspiration
|
1.4%
2/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Infections and infestations
Urinary tract infection
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Infections and infestations
Vestibular neuronitis
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Investigations
Blood creatine increased
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Investigations
Blood creatinine increased
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Investigations
Liver function test increased
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
2/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Investigations
Platelet count decreased
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.8%
4/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Musculoskeletal and connective tissue disorders
Immune-mediated myositis
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.4%
2/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
17.7%
25/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
28.2%
20/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
15.4%
22/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
2/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
2/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
1.4%
2/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Nervous system disorders
Cerebral infarction
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Nervous system disorders
Cervical cord compression
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Nervous system disorders
Hydrocephalus
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Nervous system disorders
Ischaemic stroke
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Nervous system disorders
Optic neuritis
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Psychiatric disorders
Depression
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Psychiatric disorders
Insomnia
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.4%
2/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Renal and urinary disorders
Pyelocaliectasis
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
7.0%
5/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
2/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
2.1%
3/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.5%
5/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
2/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
1.4%
2/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Skin and subcutaneous tissue disorders
Urticarial vasculitis
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Vascular disorders
Deep vein thrombosis
|
2.1%
3/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
Other adverse events
| Measure |
Arm A: Nivolumab Plus Platinum-doublet Chemotherapy
n=141 participants at risk
Nivolumab was administered IV every 3 weeks with platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) IV for a maximum of 4 cycles.
Treatment administered was either Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.
Following completion of the fourth cycle of nivolumab/chemotherapy, all participants who did not experience disease progression should have continued nivolumab 360 mg IV and pemetrexed (500 mg/m2) every 3 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, or study closure, whichever comes first. Nivolumab should only be administered for a maximum of 24 months (96 weeks) from the first study treatment.
|
Arm B: Nivolumab Plus Ipilimumab
n=71 participants at risk
Nivolumab 3 mg/kg IV was administered every 2 weeks and ipilimumab 1 mg/kg IV was administered every 6 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, a maximum of 24 months (96 weeks) from the first study treatment, or study closure.
|
Arm C: Platinum Doublet Chemotherapy
n=143 participants at risk
Platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) was administered IV in 3-week cycles for up to a maximum of 4 cycles.
Participants received either Pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.
Platinum-doublet chemotherapy continued until disease progression, unacceptable toxicity, or completion of the 4 cycles, whichever came first.
Participants who had stable disease or response after 4 cycles of pemetrexed with cisplatin or carboplatin should have continued pemetrexed alone as maintenance therapy until disease progression, or unacceptable toxicity.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
46.8%
66/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
9.9%
7/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
40.6%
58/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Blood and lymphatic system disorders
Neutropenia
|
15.6%
22/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
4.2%
3/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
4.2%
6/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.1%
10/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
4.2%
6/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Endocrine disorders
Hyperthyroidism
|
5.0%
7/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
11.3%
8/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Endocrine disorders
Hypothyroidism
|
10.6%
15/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
16.9%
12/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.1%
3/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
7.0%
5/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
7.7%
11/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.1%
3/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
5.6%
4/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
2.8%
4/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Gastrointestinal disorders
Constipation
|
36.9%
52/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
29.6%
21/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
39.9%
57/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.8%
18/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
23.9%
17/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
11.9%
17/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Gastrointestinal disorders
Nausea
|
44.7%
63/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
16.9%
12/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
42.0%
60/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Gastrointestinal disorders
Stomatitis
|
8.5%
12/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
5.6%
4/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
7.0%
10/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Gastrointestinal disorders
Vomiting
|
24.8%
35/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
9.9%
7/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
14.7%
21/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
General disorders
Asthenia
|
8.5%
12/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
4.2%
3/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
7.0%
10/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
General disorders
Face oedema
|
5.7%
8/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
6.3%
9/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
General disorders
Fatigue
|
21.3%
30/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
21.1%
15/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
13.3%
19/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
General disorders
Malaise
|
12.8%
18/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
7.0%
5/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
14.7%
21/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
General disorders
Non-cardiac chest pain
|
7.1%
10/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
9.9%
7/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
5.6%
8/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
General disorders
Oedema peripheral
|
18.4%
26/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
11.3%
8/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
12.6%
18/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
General disorders
Pyrexia
|
20.6%
29/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
19.7%
14/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
11.9%
17/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Infections and infestations
Conjunctivitis
|
7.1%
10/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
2.8%
2/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
2/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Infections and infestations
Nasopharyngitis
|
5.7%
8/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Infections and infestations
Paronychia
|
4.3%
6/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
5.6%
4/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Infections and infestations
Pneumonia
|
5.0%
7/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
7.0%
5/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
4.9%
7/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.4%
9/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
8.5%
6/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
6.3%
9/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Infections and infestations
Urinary tract infection
|
3.5%
5/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
5.6%
4/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
2.1%
3/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Investigations
Alanine aminotransferase increased
|
24.8%
35/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
16.9%
12/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
18.2%
26/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Investigations
Amylase increased
|
9.2%
13/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
4.2%
3/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
6.3%
9/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Investigations
Aspartate aminotransferase increased
|
24.8%
35/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
15.5%
11/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
18.9%
27/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Investigations
Blood creatinine increased
|
13.5%
19/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
10.5%
15/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Investigations
Neutrophil count decreased
|
29.8%
42/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
5.6%
4/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
31.5%
45/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Investigations
Platelet count decreased
|
13.5%
19/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
8.5%
6/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
19.6%
28/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Investigations
Weight decreased
|
6.4%
9/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
9.9%
7/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
4.2%
6/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Investigations
White blood cell count decreased
|
27.0%
38/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
4.2%
3/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
24.5%
35/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
29.8%
42/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
22.5%
16/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
36.4%
52/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.4%
9/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
2.8%
2/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
4.2%
6/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.8%
11/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
8.5%
6/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
4.2%
6/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.6%
15/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
12.7%
9/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
7.0%
10/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.9%
21/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
7.0%
5/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
8.4%
12/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.0%
7/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
5.6%
4/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
2.1%
3/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.3%
6/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
8.5%
6/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
2.8%
4/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.3%
6/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
7.0%
5/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
2.1%
3/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
6.4%
9/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
7.0%
5/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
6.3%
9/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.71%
1/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
5.6%
4/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
2.8%
4/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
9.9%
7/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
2.1%
3/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Nervous system disorders
Dizziness
|
10.6%
15/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
9.9%
7/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
9.8%
14/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Nervous system disorders
Dysgeusia
|
6.4%
9/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
7.0%
10/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Nervous system disorders
Headache
|
15.6%
22/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
7.0%
5/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
13.3%
19/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Psychiatric disorders
Anxiety
|
4.3%
6/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
5.6%
4/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
2.1%
3/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Psychiatric disorders
Insomnia
|
12.1%
17/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
8.5%
6/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
15.4%
22/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.3%
16/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
22.5%
16/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
12.6%
18/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.6%
15/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
19.7%
14/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
8.4%
12/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.4%
9/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
5.6%
4/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
6.3%
9/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
8.5%
12/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
2.8%
2/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
5.6%
8/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.4%
9/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
11.3%
8/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
7.7%
11/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.3%
6/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
5.6%
4/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
5.6%
8/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.4%
2/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
7.0%
5/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.1%
17/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
25.4%
18/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
5.6%
8/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
2/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
12.7%
9/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.00%
0/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.4%
9/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
2.8%
2/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
2.8%
4/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
8.5%
12/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
12.7%
9/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
0.70%
1/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
|
Vascular disorders
Hypertension
|
6.4%
9/141 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
7.0%
5/71 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
2.8%
4/143 • Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.
|
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