Trial Outcomes & Findings for Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer (NCT NCT02481830)
NCT ID: NCT02481830
Last Updated: 2023-07-27
Results Overview
The time from randomization to the date of death, data was based on Kaplan-Meier Estimates. A participant who has not died will be censored at last known date alive.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
569 participants
Primary outcome timeframe
OS was followed continuously while participants were on the study drug and every 3 months, minimum follow up for overall survival was 15.8 months
Results posted on
2023-07-27
Participant Flow
Participant milestones
| Measure |
Group A
Nivolumab 240mg IV on Day 1 of a 14-day cycle
|
Group B
Chemotherapy (Topotecan 1.5 mg/m\^2 IV or 2.3 mg/m\^2 oral once daily on Days 1 to 5 of a 21-day cycle / Amrubicin 40 mg/m\^2 IV once daily on Days 1 to 3 of a 21-day cycle)
|
|---|---|---|
|
Pre-treatment
STARTED
|
284
|
285
|
|
Pre-treatment
COMPLETED
|
282
|
265
|
|
Pre-treatment
NOT COMPLETED
|
2
|
20
|
|
Treatment
STARTED
|
282
|
265
|
|
Treatment
COMPLETED
|
0
|
0
|
|
Treatment
NOT COMPLETED
|
282
|
265
|
Reasons for withdrawal
| Measure |
Group A
Nivolumab 240mg IV on Day 1 of a 14-day cycle
|
Group B
Chemotherapy (Topotecan 1.5 mg/m\^2 IV or 2.3 mg/m\^2 oral once daily on Days 1 to 5 of a 21-day cycle / Amrubicin 40 mg/m\^2 IV once daily on Days 1 to 3 of a 21-day cycle)
|
|---|---|---|
|
Pre-treatment
Participant no longer meets Study Criteria
|
1
|
4
|
|
Pre-treatment
Withdrawal by Subject
|
0
|
10
|
|
Pre-treatment
Disease Progression
|
1
|
1
|
|
Pre-treatment
Other reasons
|
0
|
1
|
|
Pre-treatment
Participant request to discontinue study treatment
|
0
|
4
|
|
Treatment
Disease Progression
|
233
|
171
|
|
Treatment
Study drug toxicity
|
18
|
38
|
|
Treatment
Death
|
1
|
1
|
|
Treatment
Adverse Event unrelated to Study drug
|
14
|
11
|
|
Treatment
Participants request to discontinue Study treatment
|
6
|
34
|
|
Treatment
Withdrawal by Subject
|
2
|
3
|
|
Treatment
Lost to Follow-up
|
1
|
0
|
|
Treatment
Maximum Clinical Benefit
|
0
|
5
|
|
Treatment
Administrative reason by sponsor
|
1
|
1
|
|
Treatment
Other reasons
|
6
|
1
|
Baseline Characteristics
Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Group A
n=284 Participants
Nivolumab 240mg IV on Day 1 of a 14-day cycle
|
Group B
n=285 Participants
Chemotherapy (Topotecan 1.5 mg/m\^2 IV or 2.3 mg/m\^2 oral once daily on Days 1 to 5 of a 21-day cycle / Amrubicin 40 mg/m\^2 IV once daily on Days 1 to 3 of a 21-day cycle)
|
Total
n=569 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.5 Years
STANDARD_DEVIATION 9.2 • n=99 Participants
|
61.6 Years
STANDARD_DEVIATION 8.4 • n=107 Participants
|
61.6 Years
STANDARD_DEVIATION 8.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=99 Participants
|
108 Participants
n=107 Participants
|
218 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
174 Participants
n=99 Participants
|
177 Participants
n=107 Participants
|
351 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
125 Participants
n=99 Participants
|
142 Participants
n=107 Participants
|
267 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
155 Participants
n=99 Participants
|
137 Participants
n=107 Participants
|
292 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
70 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
141 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
211 Participants
n=99 Participants
|
211 Participants
n=107 Participants
|
422 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: OS was followed continuously while participants were on the study drug and every 3 months, minimum follow up for overall survival was 15.8 monthsPopulation: All Randomized Participants
The time from randomization to the date of death, data was based on Kaplan-Meier Estimates. A participant who has not died will be censored at last known date alive.
Outcome measures
| Measure |
Group A
n=284 Participants
Nivolumab 240mg IV on Day 1 of a 14-day cycle
|
Group B
n=285 Participants
Chemotherapy (Topotecan 1.5 mg/m\^2 IV or 2.3 mg/m\^2 oral once daily on Days 1 to 5 of a 21-day cycle / Amrubicin 40 mg/m\^2 IV once daily on Days 1 to 3 of a 21-day cycle)
|
|---|---|---|
|
Overall Survival (OS)
|
7.46 Months
Interval 5.65 to 9.2
|
8.38 Months
Interval 7.03 to 10.02
|
SECONDARY outcome
Timeframe: From randomization to the date of first documented tumor progression, or death due to any cause. Tumor response assessed every 6 weeks from first dose until week 30, and every 12 weeks (Up to approximately 80 months)Population: All Randomized Participants
PFS is defined as the time from randomization to the date of the first documented tumor progression based on investigator assessment (per RECIST 1.1), or death due to any cause. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die will be censored on the date they were randomized. Participants who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the last evaluable tumor assessment prior to initiation of the subsequent anti-cancer therapy. Progressive disease (PD)= At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Group A
n=284 Participants
Nivolumab 240mg IV on Day 1 of a 14-day cycle
|
Group B
n=285 Participants
Chemotherapy (Topotecan 1.5 mg/m\^2 IV or 2.3 mg/m\^2 oral once daily on Days 1 to 5 of a 21-day cycle / Amrubicin 40 mg/m\^2 IV once daily on Days 1 to 3 of a 21-day cycle)
|
|---|---|---|
|
Progression Free Survival (PFS)
|
1.45 Months
Interval 1.41 to 1.51
|
3.71 Months
Interval 2.96 to 4.24
|
SECONDARY outcome
Timeframe: From randomization to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to approximately 80 months)Population: All Randomized Participants
ORR is defined as the percentage of randomized participants whose best overall response (BOR) from baseline is either a complete response (CR) or partial response (PR) based on investigator assessment per RECIST 1.1 criteria. For participants without documented progression or subsequent anti-cancer therapy, all available response designations will contribute to the BOR determination. For participants who continue nivolumab beyond progression, the BOR should be determined based on tumor assessments before initial RECIST 1.1 defined progression. CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD)= At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Group A
n=284 Participants
Nivolumab 240mg IV on Day 1 of a 14-day cycle
|
Group B
n=285 Participants
Chemotherapy (Topotecan 1.5 mg/m\^2 IV or 2.3 mg/m\^2 oral once daily on Days 1 to 5 of a 21-day cycle / Amrubicin 40 mg/m\^2 IV once daily on Days 1 to 3 of a 21-day cycle)
|
|---|---|---|
|
Objective Response Rate (ORR)
|
13.7 Percentage of Participants
Interval 10.0 to 18.3
|
16.8 Percentage of Participants
Interval 12.7 to 21.7
|
POST_HOC outcome
Timeframe: OS was followed continuously while participants were on the study drug and every 3 months, minimum follow up for overall survival was 64 months (Up to approximately 80 months)Population: All Randomized Participants
The time from randomization to the date of death, data was based on Kaplan-Meier Estimates. A participant who has not died will be censored at last known date alive.
Outcome measures
| Measure |
Group A
n=284 Participants
Nivolumab 240mg IV on Day 1 of a 14-day cycle
|
Group B
n=285 Participants
Chemotherapy (Topotecan 1.5 mg/m\^2 IV or 2.3 mg/m\^2 oral once daily on Days 1 to 5 of a 21-day cycle / Amrubicin 40 mg/m\^2 IV once daily on Days 1 to 3 of a 21-day cycle)
|
|---|---|---|
|
Overall Survival (OS) - Extended Collection
|
7.46 Months
Interval 5.65 to 9.2
|
8.38 Months
Interval 7.03 to 10.02
|
Adverse Events
Group A
Serious events: 183 serious events
Other events: 249 other events
Deaths: 251 deaths
Group B
Serious events: 171 serious events
Other events: 248 other events
Deaths: 256 deaths
Serious adverse events
| Measure |
Group A
n=282 participants at risk
Nivolumab 240mg IV on Day 1 of a 14-day cycle
|
Group B
n=265 participants at risk
Chemotherapy (Topotecan 1.5 mg/m\^2 IV or 2.3 mg/m\^2 oral once daily on Days 1 to 5 of a 21-day cycle / Amrubicin 40 mg/m\^2 IV once daily on Days 1 to 3 of a 21-day cycle)
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.1%
3/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
14/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bone marrow failure
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.5%
7/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.7%
23/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
3/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lymphadenopathy
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.8%
10/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
11/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.0%
8/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
15/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.71%
2/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 tamponade
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pericardial effusion
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cushing's syndrome
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hyperthyroidism
|
0.71%
2/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.75%
2/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Secondary adrenocortical insufficiency
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 obstructive
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
4/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.5%
4/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.71%
2/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
4/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Gastrooesophageal reflux disease
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Intestinal haemorrhage
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Intestinal obstruction
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.71%
2/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.75%
2/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Oral disorder
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 haemorrhage
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.71%
2/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.9%
5/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Death
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.8%
8/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.3%
6/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Multiple organ dysfunction syndrome
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.75%
2/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
4/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
3/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Sudden death
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 failure
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Jaundice cholestatic
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Appendicitis
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bacteraemia
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.71%
2/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 bacterial
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bullous erysipelas
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cellulitis
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Chronic sinusitis
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Enterocolitis infectious
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Erysipelas
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Herpes simplex
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Infective exacerbation of chronic obstructive airways disease
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Localised infection
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Neutropenic sepsis
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.5%
4/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Ophthalmic herpes zoster
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Peritonsillar abscess
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.3%
15/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.4%
9/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 bacterial
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Post procedural infection
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pulmonary sepsis
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.1%
3/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.75%
2/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.71%
2/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.75%
2/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Urinary tract infection
|
0.71%
2/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Vascular device infection
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.75%
2/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bone contusion
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Contusion
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Femoral neck fracture
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Injection related reaction
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Synovial rupture
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Toxicity to various agents
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 electrolytes abnormal
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.75%
2/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Gamma-glutamyltransferase increased
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.71%
2/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Neutrophil count decreased
|
0.71%
2/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.5%
4/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Platelet count decreased
|
1.4%
4/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.8%
10/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
White blood cell count decreased
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.75%
2/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Electrolyte imbalance
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Glucose tolerance impaired
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hyperglycaemia
|
0.71%
2/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.8%
5/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
3/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 1 diabetes mellitus
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.75%
2/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Arthritis
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bone pain
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Osteonecrosis of jaw
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Osteoporotic fracture
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.71%
2/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pathological fracture
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Adenocarcinoma
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Epiglottic cancer
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Lung neoplasm malignant
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
38.3%
108/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
32.1%
85/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Pericardial effusion malignant
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Second primary malignancy
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Squamous cell carcinoma of lung
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Squamous cell carcinoma of the tongue
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Tongue neoplasm
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Tumour invasion
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Tumour pain
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Brain oedema
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cerebellar ataxia
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.75%
2/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Epilepsy
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Haemorrhage intracranial
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hemiparesis
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lacunar infarction
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Paraneoplastic neurological syndrome
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Spinal cord compression
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Toxic encephalopathy
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Confusional state
|
0.71%
2/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.75%
2/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Delirium
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Disorientation
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bladder dilatation
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.75%
2/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 pulmonary oedema
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Atelectasis
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bronchial obstruction
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.75%
2/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
3.2%
9/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.0%
8/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Epistaxis
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Haemoptysis
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
3/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.71%
2/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lung infiltration
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Mediastinal disorder
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Oesophagobronchial fistula
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.71%
2/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.75%
2/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
3.5%
10/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.5%
4/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 haemorrhage
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.71%
2/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.75%
2/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Dermatitis
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Paraneoplastic pemphigus
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Stevens-Johnson syndrome
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.35%
1/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Poor venous access
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Shock
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.75%
2/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 |
Group A
n=282 participants at risk
Nivolumab 240mg IV on Day 1 of a 14-day cycle
|
Group B
n=265 participants at risk
Chemotherapy (Topotecan 1.5 mg/m\^2 IV or 2.3 mg/m\^2 oral once daily on Days 1 to 5 of a 21-day cycle / Amrubicin 40 mg/m\^2 IV once daily on Days 1 to 3 of a 21-day cycle)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
24.1%
68/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
61.5%
163/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.3%
12/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.5%
41/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.0%
17/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
35.1%
93/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.7%
19/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
29.4%
78/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.2%
23/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.38%
1/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.7%
19/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
14/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.7%
16/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
11/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
16.0%
45/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.5%
49/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
12.1%
34/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
16.6%
44/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
17.0%
48/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
22.3%
59/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Stomatitis
|
4.3%
12/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.4%
17/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
11.7%
33/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.5%
41/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
23.0%
65/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
22.6%
60/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
22.3%
63/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
29.4%
78/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.3%
12/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.4%
17/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
9.9%
28/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
14.0%
37/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.7%
16/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
22/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.3%
15/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
13/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.8%
8/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
16/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
7.8%
22/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
13/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.3%
15/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.75%
2/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
7.8%
22/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
16/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.7%
16/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.4%
9/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Gamma-glutamyltransferase increased
|
7.1%
20/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
11/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Haemoglobin decreased
|
1.8%
5/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
14/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
9.6%
27/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.5%
4/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Neutrophil count decreased
|
9.9%
28/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
22.6%
60/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Platelet count decreased
|
7.1%
20/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
23.8%
63/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
9.2%
26/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
16/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
White blood cell count decreased
|
9.2%
26/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
17.4%
46/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
28.0%
79/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
70/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hyperglycaemia
|
5.3%
15/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.0%
8/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.7%
19/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.8%
18/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.5%
24/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.4%
25/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
9.6%
27/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.4%
17/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
10.6%
30/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.4%
25/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.7%
16/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
11/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
7.1%
20/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.4%
17/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
10.6%
30/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.9%
21/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.2%
23/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.4%
17/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
22.3%
63/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
19.6%
52/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
22.3%
63/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
17.0%
45/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Epistaxis
|
0.71%
2/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
15/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
7.1%
20/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.0%
8/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Alopecia
|
1.4%
4/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.8%
26/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
9.6%
27/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.5%
4/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
7.4%
21/282 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
11/265 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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: 1(800) 332-2056
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