Trial Outcomes & Findings for Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients (NCT NCT02899299)
NCT ID: NCT02899299
Last Updated: 2024-05-21
Results Overview
Overall Survival was defined as the time from randomization to the date of death due to any cause. A participant who has not died was censored at last known date alive.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
605 participants
Primary outcome timeframe
From randomization to the date of death (Up to 40 Months)
Results posted on
2024-05-21
Participant Flow
Participant milestones
| Measure |
Treatment A
Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
|
Treatment B
Pemetrexed 500 mg/m\^2 + Cisplatin 75 mg/m\^2 or Carboplatin 5 AUC up to 6 cycles
|
|---|---|---|
|
Pre-treatment
STARTED
|
303
|
302
|
|
Pre-treatment
COMPLETED
|
300
|
284
|
|
Pre-treatment
NOT COMPLETED
|
3
|
18
|
|
Treatment
STARTED
|
300
|
284
|
|
Treatment
COMPLETED
|
0
|
189
|
|
Treatment
NOT COMPLETED
|
300
|
95
|
Reasons for withdrawal
| Measure |
Treatment A
Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
|
Treatment B
Pemetrexed 500 mg/m\^2 + Cisplatin 75 mg/m\^2 or Carboplatin 5 AUC up to 6 cycles
|
|---|---|---|
|
Pre-treatment
Participant request to discontinue study treatment
|
0
|
3
|
|
Pre-treatment
Participant withdrew consent
|
1
|
11
|
|
Pre-treatment
Participant no longer meets study criteria
|
2
|
3
|
|
Pre-treatment
Not reported
|
0
|
1
|
|
Treatment
Disease Progression
|
182
|
43
|
|
Treatment
Study Drug Toxicity
|
60
|
24
|
|
Treatment
Adverse Event unrelated to Study Drug
|
11
|
9
|
|
Treatment
Participant request to discontinue Study treatment
|
4
|
10
|
|
Treatment
Participant withdrew consent
|
6
|
3
|
|
Treatment
Lost to Follow-up
|
0
|
2
|
|
Treatment
Maximum Clinical Benefit
|
11
|
2
|
|
Treatment
Poor/Non-compliance
|
1
|
0
|
|
Treatment
Participant no longer meets Study criteria
|
4
|
0
|
|
Treatment
Administrative reason by Sponsor
|
2
|
0
|
|
Treatment
Other reasons
|
12
|
2
|
|
Treatment
Not reported
|
7
|
0
|
Baseline Characteristics
Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients
Baseline characteristics by cohort
| Measure |
Treatment A
n=303 Participants
Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
|
Treatment B
n=302 Participants
Pemetrexed 500 mg/m\^2 + Cisplatin 75 mg/m\^2 or Carboplatin 5 AUC up to 6 cycles
|
Total
n=605 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.7 Years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
67.8 Years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
68.2 Years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
234 Participants
n=5 Participants
|
233 Participants
n=7 Participants
|
467 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
122 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
258 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
162 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
309 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
26 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
266 Participants
n=5 Participants
|
250 Participants
n=7 Participants
|
516 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to the date of death (Up to 40 Months)Population: All Randomized Participants
Overall Survival was defined as the time from randomization to the date of death due to any cause. A participant who has not died was censored at last known date alive.
Outcome measures
| Measure |
Treatment A
n=303 Participants
Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
|
Treatment B
n=302 Participants
Pemetrexed 500 mg/m\^2 + Cisplatin 75 mg/m\^2 or Carboplatin 5 AUC up to 6 cycles
|
|---|---|---|
|
Overall Survival (OS)
|
18.07 Months
Interval 16.82 to 21.45
|
14.09 Months
Interval 12.45 to 16.23
|
SECONDARY outcome
Timeframe: From randomization date to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to 76 months)Population: All Randomized Participants
Objective Response Rate is defined as the percentage of randomized participants who achieve a best overall response of complete response (CR) or partial response (PR) per Blinded Independent Central Review (BICR) assessments. Per adapted m-RECIST for pleural mesothelioma, each single tumor measurement must be at least 10 mm in length to qualify as measureable disease and contribute to the sum that defines the pleural uni-variate measure. Per RECIST 1.1 for solid tumors, confirmation of response required: CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the Total Tumor Measurement; Progressive disease (PD)=At least a 20% increase in the sum of the Total Tumor Measurement.
Outcome measures
| Measure |
Treatment A
n=303 Participants
Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
|
Treatment B
n=302 Participants
Pemetrexed 500 mg/m\^2 + Cisplatin 75 mg/m\^2 or Carboplatin 5 AUC up to 6 cycles
|
|---|---|---|
|
Objective Response Rate (ORR)
|
39.3 Percentage of Participants
Interval 33.7 to 45.0
|
44.4 Percentage of Participants
Interval 38.7 to 50.2
|
SECONDARY outcome
Timeframe: From randomization date to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to 76 monthsPopulation: All Randomized Participants
Disease Control Rate is defined as the percentage of all randomized participants whose Best Overall Response was complete response (CR), partial response (PR), stable disease (SD) or Non-CR/Non-PD as assessed by Blinded Independent Central Review (BICR). Per adapted m-RECIST for pleural mesothelioma, each single tumor measurement must be at least 10 mm in length to qualify as measureable disease and contribute to the sum that defines the pleural uni-variate measure. Per RECIST 1.1 for solid tumors, confirmation of response required: CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the Total Tumor Measurement; Progressive disease (PD)=At least a 20% increase in the sum of the Total Tumor Measurement; SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Non-CR/Non-PD: Persistence of one or more non-target lesion(s).
Outcome measures
| Measure |
Treatment A
n=303 Participants
Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
|
Treatment B
n=302 Participants
Pemetrexed 500 mg/m\^2 + Cisplatin 75 mg/m\^2 or Carboplatin 5 AUC up to 6 cycles
|
|---|---|---|
|
Disease Control Rate (DCR)
|
76.6 Percentage of Participants
Interval 71.4 to 81.2
|
85.8 Percentage of Participants
Interval 81.3 to 89.5
|
SECONDARY outcome
Timeframe: From randomization date to the date of first documented tumor progression or death due to any cause, whichever occurs first. (up to 76 months)Population: All Randomized Participants
Progression Free Survival is defined as the time between the date of randomization and the date of first documented tumor progression per Blinded Independent Central Review (BICR) assessments (using adapted m-RECIST and RECIST 1.1), or death due to any cause, whichever occurs first. Participants who received subsequent anticancer therapy prior to documented progression were censored at the date of the last evaluable tumor assessment conducted on or prior to the date of initiation of the subsequent anticancer therapy. Progressive disease (PD)=At least a 20% increase in the sum of the Total Tumor Measurement.
Outcome measures
| Measure |
Treatment A
n=303 Participants
Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
|
Treatment B
n=302 Participants
Pemetrexed 500 mg/m\^2 + Cisplatin 75 mg/m\^2 or Carboplatin 5 AUC up to 6 cycles
|
|---|---|---|
|
Progression Free Survival (PFS)
|
6.77 Months
Interval 5.59 to 7.36
|
7.23 Months
Interval 6.93 to 8.05
|
SECONDARY outcome
Timeframe: From randomization date to the date of death (Up to 76 Months)Population: All PD-L1 evaluable participants with baseline expression \<1% or ≥1%
PD-L1 Expression is defined as the percent of tumor cells membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 immunohistochemistry (IHC) assay. This is referred to as quantifiable PD-L1 expression and efficacy is determined by overall survival (OS) analysis. OS was defined as the time from randomization to the date of death due to any cause. A participant who has not died was censored at last known date alive.
Outcome measures
| Measure |
Treatment A
n=289 Participants
Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
|
Treatment B
n=297 Participants
Pemetrexed 500 mg/m\^2 + Cisplatin 75 mg/m\^2 or Carboplatin 5 AUC up to 6 cycles
|
|---|---|---|
|
Overall Survival (OS) According to PD-L1 Expression Level
<1% PD-L1
|
17.3 Months
Interval 10.1 to 23.9
|
16.6 Months
Interval 13.4 to 20.8
|
|
Overall Survival (OS) According to PD-L1 Expression Level
≥1% PD-L1
|
18.0 Months
Interval 16.8 to 21.5
|
13.3 Months
Interval 11.6 to 15.4
|
SECONDARY outcome
Timeframe: From randomization date to the date of first documented tumor progression or death due to any cause, whichever occurs first. (up to 76 months)Population: All PD-L1 evaluable participants with baseline expression \<1% or ≥1%
PD-L1 Expression is defined as the percent of tumor cells membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 immunohistochemistry (IHC) assay. This is referred to as quantifiable PD-L1 expression and efficacy is determined by progression free survival (PFS) analysis. PFS is defined as the time between the date of randomization and the date of first documented tumor progression per Blinded Independent Central Review (BICR) assessments (using adapted m-RECIST and RECIST 1.1), or death due to any cause, whichever occurs first. Participants who received subsequent anticancer therapy prior to documented progression were censored at the date of the last evaluable tumor assessment conducted on or prior to the date of initiation of the subsequent anticancer therapy. Progressive disease (PD)=At least a 20% increase in the sum of the Total Tumor Measurement.
Outcome measures
| Measure |
Treatment A
n=289 Participants
Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
|
Treatment B
n=297 Participants
Pemetrexed 500 mg/m\^2 + Cisplatin 75 mg/m\^2 or Carboplatin 5 AUC up to 6 cycles
|
|---|---|---|
|
Progression Free Survival (PFS) According to PD-L1 Expression Level
<1% PD-L1
|
4.1 Months
Interval 2.7 to 5.6
|
8.3 Months
Interval 7.0 to 11.1
|
|
Progression Free Survival (PFS) According to PD-L1 Expression Level
≥1% PD-L1
|
7.0 Months
Interval 5.8 to 8.5
|
7.1 Months
Interval 6.2 to 7.6
|
SECONDARY outcome
Timeframe: From randomization date to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to 76 months)Population: All PD-L1 evaluable participants with baseline expression \<1% or ≥1%
PD-L1 Expression is defined as the percent of tumor cells membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 immunohistochemistry (IHC) assay. This is referred to as quantifiable PD-L1 expression and efficacy is determined by objective response rate (ORR) analysis. ORR is defined as the percentage of participants who achieve a best overall response of complete response (CR) or partial response (PR) per Blinded Independent Central Review (BICR) assessments. Per adapted m-RECIST for pleural mesothelioma, each single tumor measurement must be at least 10 mm in length to qualify as measureable disease and contribute to the sum that defines the pleural uni-variate measure. per RECIST 1.1 for solid tumors, confirmation of response required: CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the Total Tumor Measurement; Progressive disease (PD)=At least a 20% increase in the sum of the Total Tumor Measurement.
Outcome measures
| Measure |
Treatment A
n=289 Participants
Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
|
Treatment B
n=297 Participants
Pemetrexed 500 mg/m\^2 + Cisplatin 75 mg/m\^2 or Carboplatin 5 AUC up to 6 cycles
|
|---|---|---|
|
Objective Response Rate (ORR) According to PD-L1 Expression Level
<1% PD-L1
|
21.1 Percentage of Participants
Interval 11.4 to 33.9
|
41.0 Percentage of Participants
Interval 30.0 to 52.7
|
|
Objective Response Rate (ORR) According to PD-L1 Expression Level
≥1% PD-L1
|
43.1 Percentage of Participants
Interval 36.6 to 49.7
|
45.7 Percentage of Participants
Interval 38.9 to 52.5
|
POST_HOC outcome
Timeframe: From randomization date to the date of death (Up to 76 Months)Population: All Randomized Participants
Overall Survival was defined as the time from randomization to the date of death due to any cause. A participant who has not died was censored at last known date alive.
Outcome measures
| Measure |
Treatment A
n=303 Participants
Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
|
Treatment B
n=302 Participants
Pemetrexed 500 mg/m\^2 + Cisplatin 75 mg/m\^2 or Carboplatin 5 AUC up to 6 cycles
|
|---|---|---|
|
Extended Collection: Overall Survival (OS)
|
18.07 Months
Interval 16.82 to 20.99
|
14.09 Months
Interval 12.45 to 16.33
|
Adverse Events
Nivolumab 3mg/kg Plus Ipilimumab 1mg/kg
Serious events: 188 serious events
Other events: 277 other events
Deaths: 251 deaths
Pemetrexed Plus Cisplatin or Carboplatin
Serious events: 106 serious events
Other events: 264 other events
Deaths: 259 deaths
Serious adverse events
| Measure |
Nivolumab 3mg/kg Plus Ipilimumab 1mg/kg
n=300 participants at risk
Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
|
Pemetrexed Plus Cisplatin or Carboplatin
n=284 participants at risk
Pemetrexed 500 mg/m\^2 + Cisplatin 75 mg/m\^2 or Carboplatin 5 AUC up to 6 cycles
|
|---|---|---|
|
General disorders
Oedema peripheral
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Pain
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Performance status decreased
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Pyrexia
|
5.3%
16/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
4/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.0%
3/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.67%
2/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.7%
5/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatitis
|
1.0%
3/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
1.7%
5/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Immune system disorders
Contrast media allergy
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Immune system disorders
Infusion related hypersensitivity reaction
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Abscess intestinal
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Arthritis bacterial
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Bronchitis
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Candida sepsis
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Device related infection
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Empyema
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Encephalitis
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Infectious pleural effusion
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Influenza
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Klebsiella urinary tract infection
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.67%
2/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Otitis externa fungal
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pleural infection
|
0.67%
2/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pleurisy bacterial
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia
|
4.7%
14/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.1%
6/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia aspiration
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Respiratory tract infection
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Sepsis
|
1.0%
3/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.70%
2/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Septic shock
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Skin infection
|
0.67%
2/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.0%
6/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood creatinine increased
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
C-reactive protein increased
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
General physical condition abnormal
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.67%
2/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.3%
4/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.70%
2/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
3/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.67%
2/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.70%
2/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
17.0%
51/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
14.8%
42/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma malignant
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.67%
2/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Cognitive disorder
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Limbic encephalitis
|
0.67%
2/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Migraine
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Myasthenia gravis
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Myasthenic syndrome
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Myelitis transverse
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Neurological symptom
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Presyncope
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Seizure
|
0.67%
2/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Syncope
|
1.0%
3/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Depression
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.3%
7/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.70%
2/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Haematuria
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Renal failure
|
0.67%
2/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Renal impairment
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Urinary retention
|
0.67%
2/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.0%
3/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.0%
9/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.8%
8/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.70%
2/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.0%
3/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.0%
9/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.1%
3/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
1.0%
3/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.0%
9/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.67%
2/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.70%
2/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.0%
6/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.1%
3/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.67%
2/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Cutaneous vasculitis
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.67%
2/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Embolism
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Giant cell arteritis
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
5/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.2%
9/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.1%
3/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Haematotoxicity
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.1%
3/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenic purpura
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
1.0%
3/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Atrial flutter
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Atrial thrombosis
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac arrest
|
0.67%
2/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac failure
|
0.67%
2/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac failure acute
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiomyopathy
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Myocardial infarction
|
0.67%
2/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Myocarditis
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Pleuropericarditis
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Tachycardia
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Adrenal insufficiency
|
1.0%
3/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Adrenocorticotropic hormone deficiency
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hypophysitis
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hypopituitarism
|
1.3%
4/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Opsoclonus myoclonus
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Retinal detachment
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
5/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.70%
2/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Anal fissure
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Ascites
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Colitis
|
3.0%
9/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
5/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dysphagia
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Enteritis
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.67%
2/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastritis
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Ileus
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Overflow diarrhoea
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.0%
3/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Superior mesenteric artery dissection
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.70%
2/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Asthenia
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.70%
2/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Chest pain
|
1.3%
4/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
4/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
General physical health deterioration
|
0.67%
2/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Hyperpyrexia
|
0.67%
2/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Hyperthermia
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Illness
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Malaise
|
0.67%
2/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Non-cardiac chest pain
|
1.3%
4/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.35%
1/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
Other adverse events
| Measure |
Nivolumab 3mg/kg Plus Ipilimumab 1mg/kg
n=300 participants at risk
Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
|
Pemetrexed Plus Cisplatin or Carboplatin
n=284 participants at risk
Pemetrexed 500 mg/m\^2 + Cisplatin 75 mg/m\^2 or Carboplatin 5 AUC up to 6 cycles
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
13.7%
41/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
41.5%
118/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.8%
25/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.7%
5/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
27.8%
79/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.7%
5/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.3%
32/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hypothyroidism
|
12.3%
37/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.1%
3/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Lacrimation increased
|
0.33%
1/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.7%
19/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
30/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.6%
13/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
19.0%
57/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
30.3%
86/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
32.0%
96/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.0%
34/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
25.3%
76/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
43.7%
124/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
15.7%
47/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
19.4%
55/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Asthenia
|
17.3%
52/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
20.4%
58/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Chest pain
|
7.3%
22/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.4%
21/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
30.0%
90/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
27.5%
78/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Malaise
|
2.7%
8/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.0%
17/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Non-cardiac chest pain
|
13.0%
39/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.6%
16/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Oedema peripheral
|
15.7%
47/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.7%
19/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Pain
|
6.7%
20/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.9%
11/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Pyrexia
|
16.7%
50/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.9%
14/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
7.0%
21/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.8%
8/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
7.3%
22/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.70%
2/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
7.3%
22/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
4/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Amylase increased
|
8.0%
24/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
4/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.0%
18/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.1%
3/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood creatinine increased
|
8.7%
26/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.7%
19/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Lipase increased
|
9.0%
27/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
4/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Weight decreased
|
5.7%
17/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.5%
24/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
24.0%
72/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
26.4%
75/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.3%
19/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.9%
11/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.3%
19/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.9%
11/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.3%
49/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.2%
9/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.0%
21/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.6%
13/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.0%
24/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.5%
7/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.0%
18/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.2%
9/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
5.3%
16/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.5%
10/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Dysgeusia
|
5.0%
15/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.7%
22/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
8.0%
24/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
12/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Neuropathy peripheral
|
1.0%
3/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.3%
15/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
9.0%
27/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.6%
16/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.7%
65/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.8%
25/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.7%
77/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
14.4%
41/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.67%
2/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.0%
17/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.3%
16/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.5%
7/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.7%
62/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.8%
5/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
60/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.4%
21/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.0%
18/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.8%
5/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Hypertension
|
5.3%
16/300 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.8%
8/284 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
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