Trial Outcomes & Findings for Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214) (NCT NCT02231749)
NCT ID: NCT02231749
Last Updated: 2026-05-27
Results Overview
ORR was defined as the proportion of randomized subjects who achieved a best response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria based on Independent Radiology Review Committee (IRRC) assessment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1096 participants
Primary outcome timeframe
From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months)
Results posted on
2026-05-27
Participant Flow
A total of 1096 participants were randomized, with 550 assigned to the Nivolumab + Ipilimumab group and 546 assigned to the Sunitinib group. Of these, 1082 participants received at least one dose of study treatment, including 547 in the Nivolumab + Ipilimumab group and 535 in the Sunitinib group.
Participant milestones
| Measure |
Nivolumab + Ipilimumab
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
|
Sunitinib
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
|
|---|---|---|
|
Pre-treatment Period
STARTED
|
550
|
546
|
|
Pre-treatment Period
COMPLETED
|
547
|
535
|
|
Pre-treatment Period
NOT COMPLETED
|
3
|
11
|
|
Treatment Period
STARTED
|
547
|
535
|
|
Treatment Period
Crossover Extension Phase (Arm B)
|
0
|
25
|
|
Treatment Period
COMPLETED
|
0
|
2
|
|
Treatment Period
NOT COMPLETED
|
547
|
533
|
Reasons for withdrawal
| Measure |
Nivolumab + Ipilimumab
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
|
Sunitinib
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
|
|---|---|---|
|
Pre-treatment Period
Disease progression
|
0
|
1
|
|
Pre-treatment Period
Participant request to discontinue study treatment
|
1
|
2
|
|
Pre-treatment Period
Withdrawal by Subject
|
1
|
6
|
|
Pre-treatment Period
Poor/Non-compliance
|
0
|
2
|
|
Pre-treatment Period
Participant no longer meet study criteria
|
1
|
0
|
|
Treatment Period
Disease Progression
|
269
|
366
|
|
Treatment Period
Study Drug Toxicity
|
152
|
73
|
|
Treatment Period
Death
|
2
|
1
|
|
Treatment Period
Adverse Event
|
45
|
35
|
|
Treatment Period
Participant Request to Discontinue Study Treatment
|
19
|
22
|
|
Treatment Period
Withdrawal by Subject
|
12
|
9
|
|
Treatment Period
Lost to Follow-up
|
0
|
2
|
|
Treatment Period
Maximum Clinical Benefit
|
20
|
6
|
|
Treatment Period
Poor/Non-compliance
|
1
|
1
|
|
Treatment Period
Pregnancy
|
1
|
0
|
|
Treatment Period
Participant No Longer Meet Study Criteria
|
1
|
0
|
|
Treatment Period
Administration Reason by Sponsor
|
1
|
0
|
|
Treatment Period
Other Reasons
|
24
|
18
|
Baseline Characteristics
All Randomized
Baseline characteristics by cohort
| Measure |
Nivolumab + Ipilimumab
n=550 Participants
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
|
Sunitinib
n=546 Participants
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
|
Total
n=1096 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.1 Years
STANDARD_DEVIATION 9.76 • n=51 Participants • All Randomized
|
60.7 Years
STANDARD_DEVIATION 10.10 • n=14 Participants • All Randomized
|
60.9 Years
STANDARD_DEVIATION 9.93 • n=65 Participants • All Randomized
|
|
Sex: Female, Male
Female
|
137 Participants
n=51 Participants • All Randomized Participants
|
151 Participants
n=14 Participants • All Randomized Participants
|
288 Participants
n=65 Participants • All Randomized Participants
|
|
Sex: Female, Male
Male
|
413 Participants
n=51 Participants • All Randomized Participants
|
395 Participants
n=14 Participants • All Randomized Participants
|
808 Participants
n=65 Participants • All Randomized Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=51 Participants
|
17 Participants
n=14 Participants
|
29 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
264 Participants
n=51 Participants
|
253 Participants
n=14 Participants
|
517 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
274 Participants
n=51 Participants
|
276 Participants
n=14 Participants
|
550 Participants
n=65 Participants
|
|
Race/Ethnicity, Customized
White
|
486 Participants
n=51 Participants • All Randomized Participants
|
483 Participants
n=14 Participants • All Randomized Participants
|
969 Participants
n=65 Participants • All Randomized Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=51 Participants • All Randomized Participants
|
6 Participants
n=14 Participants • All Randomized Participants
|
13 Participants
n=65 Participants • All Randomized Participants
|
|
Race/Ethnicity, Customized
Asian
|
46 Participants
n=51 Participants • All Randomized Participants
|
47 Participants
n=14 Participants • All Randomized Participants
|
93 Participants
n=65 Participants • All Randomized Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=51 Participants • All Randomized Participants
|
0 Participants
n=14 Participants • All Randomized Participants
|
0 Participants
n=65 Participants • All Randomized Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=51 Participants • All Randomized Participants
|
0 Participants
n=14 Participants • All Randomized Participants
|
0 Participants
n=65 Participants • All Randomized Participants
|
|
Race/Ethnicity, Customized
Other
|
10 Participants
n=51 Participants • All Randomized Participants
|
10 Participants
n=14 Participants • All Randomized Participants
|
20 Participants
n=65 Participants • All Randomized Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
1 Participants
n=51 Participants • All Randomized Participants
|
0 Participants
n=14 Participants • All Randomized Participants
|
1 Participants
n=65 Participants • All Randomized Participants
|
PRIMARY outcome
Timeframe: From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months)Population: All Intermediate/Poor-Risk Participants
ORR was defined as the proportion of randomized subjects who achieved a best response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria based on Independent Radiology Review Committee (IRRC) assessment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Nivolumab + Ipilimumab
n=425 Participants
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
|
Sunitinib
n=422 Participants
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
|
|---|---|---|
|
Objective Response Rate (ORR) in Intermediate/Poor Risk Participants Per Independent Radiology Review Committee (IRRC) Using RECIST v1.1
|
41.6 percentage of participants
Interval 36.9 to 46.5
|
26.5 percentage of participants
Interval 22.4 to 31.0
|
PRIMARY outcome
Timeframe: From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months)Population: All Intermediate/Poor-Risk Participants
OS was defined as the time from randomization to the date of death from any cause. Survival time was censored at the date of last contact ("last known alive date") for subjects who were alive.
Outcome measures
| Measure |
Nivolumab + Ipilimumab
n=425 Participants
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
|
Sunitinib
n=422 Participants
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
|
|---|---|---|
|
Overall Survival (OS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)
|
NA months
Interval 28.16 to
The median for Overall Survival and Upper Limit have not been reached. There were an insufficient number of participants with events.
|
25.95 months
Interval 22.08 to
The median for Overall Survival and Upper Limit have not been reached. There were an insufficient number of participants with events.
|
PRIMARY outcome
Timeframe: From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to June 2017, approximately 31 months)Population: All Intermediate/Poor-Risk Participants
PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the IRRC (as per RECIST 1.1 criteria), or death due to any cause, whichever occurred first. Subsequent therapy included anticancer therapy, tumor directed radiotherapy, or tumor directed surgery. Subjects who died without a reported progression were considered to have progressed on the date of their death.
Outcome measures
| Measure |
Nivolumab + Ipilimumab
n=425 Participants
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
|
Sunitinib
n=422 Participants
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
|
|---|---|---|
|
Progression-Free Survival (PFS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)
|
11.56 months
Interval 8.71 to 15.51
|
8.38 months
Interval 7.03 to 10.81
|
SECONDARY outcome
Timeframe: From the date of randomization until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to approximately 125 months and 6 days)Population: All Randomized
ORR was defined as the proportion of randomized subjects who achieved a best response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria based on IRRC assessment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Nivolumab + Ipilimumab
n=550 Participants
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
|
Sunitinib
n=546 Participants
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
|
|---|---|---|
|
Investigator-assessed Objective Response Rate(ORR) in Any Risk Participants Per IRRC Using RECIST v1.1
|
39.5 percentage of participants
Interval 35.3 to 43.7
|
33.0 percentage of participants
Interval 29.0 to 37.1
|
SECONDARY outcome
Timeframe: From the date of randomization to the date of death (assessed up to approximately 125 months and 6 days)Population: All Randomized
Overall survival is defined as the time from randomization to the date of death from any cause. For subjects that are alive, their survival time will be censored at the date of last contact ("last known alive date"). Overall survival will be censored for subjects at the date of randomization if they were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after subject's off-treatment date.
Outcome measures
| Measure |
Nivolumab + Ipilimumab
n=550 Participants
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
|
Sunitinib
n=546 Participants
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
|
|---|---|---|
|
Overall Survival (OS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)
|
52.70 months
Interval 45.8 to 64.36
|
37.75 months
Interval 31.93 to 43.76
|
SECONDARY outcome
Timeframe: From the date of randomization to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to approximately 125 months and 6 days)Population: All Randomized
PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the IRRC (as per RECIST 1.1 criteria), or death due to any cause, whichever occurred first. Subsequent therapy included anticancer therapy, tumor directed radiotherapy, or tumor directed surgery. Subjects who died without a reported progression were considered to have progressed on the date of their death.
Outcome measures
| Measure |
Nivolumab + Ipilimumab
n=550 Participants
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
|
Sunitinib
n=546 Participants
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
|
|---|---|---|
|
Progression-Free Survival (PFS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)
|
12.42 months
Interval 9.89 to 16.56
|
12.32 months
Interval 9.79 to 15.24
|
Adverse Events
Nivolumab + Ipilimumab
Serious events: 367 serious events
Other events: 534 other events
Deaths: 367 deaths
Sunitinib
Serious events: 277 serious events
Other events: 523 other events
Deaths: 417 deaths
Sunitinib Crossover
Serious events: 6 serious events
Other events: 25 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Nivolumab + Ipilimumab
n=547 participants at risk
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
|
Sunitinib
n=535 participants at risk
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
|
Sunitinib Crossover
n=25 participants at risk
Participants received Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240 mg flat dose IV every 2 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
7/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
1.7%
9/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Autoimmune neutropenia
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Splenic lesion
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.56%
3/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.55%
3/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Angina pectoris
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Arrhythmia
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
0.55%
3/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac arrest
|
0.55%
3/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac failure
|
0.73%
4/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.56%
3/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.56%
3/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Myocardial infarction
|
1.5%
8/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Myocarditis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Pericardial effusion
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Congenital, familial and genetic disorders
Thyroglossal cyst
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Ear and labyrinth disorders
Vertigo
|
0.55%
3/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.0%
1/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Addison's disease
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Adrenal insufficiency
|
2.4%
13/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Adrenocorticotropic hormone deficiency
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Autoimmune hypothyroidism
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Goitre
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Graves' disease
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hyperthyroidism
|
0.55%
3/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hypophysitis
|
2.6%
14/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hypopituitarism
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hypothalamo-pituitary disorder
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hypothyroidism
|
0.55%
3/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Secondary adrenocortical insufficiency
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Steroid withdrawal syndrome
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Thyroiditis
|
0.55%
3/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Cataract
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Diplopia
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Eye pain
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Glaucoma
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Inflammation of lacrimal passage
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Macular hole
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Visual field defect
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
8/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
1.1%
6/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.0%
1/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Colitis
|
2.0%
11/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dental caries
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
29/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.93%
5/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Duodenitis haemorrhagic
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dysphagia
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.0%
1/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastritis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
1.1%
6/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Ileus
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Malabsorption
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
1.8%
10/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.56%
3/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.3%
7/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
1.1%
6/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.56%
3/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.0%
1/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
7/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.75%
4/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
General disorders
Adhesion
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
General disorders
Asthenia
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
1.1%
6/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
General disorders
Chest discomfort
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
General disorders
Chest pain
|
0.73%
4/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
General disorders
Death
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
0.73%
4/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
1.1%
6/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
General disorders
Gait disturbance
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
General disorders
General physical health deterioration
|
1.5%
8/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
1.5%
8/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
General disorders
Influenza like illness
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
General disorders
Malaise
|
0.55%
3/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
General disorders
Oedema peripheral
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
General disorders
Pain
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.75%
4/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
General disorders
Pyrexia
|
4.9%
27/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
1.7%
9/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
General disorders
Sudden death
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.56%
3/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.75%
4/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.0%
1/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatitis
|
0.73%
4/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Immune system disorders
Autoimmune disorder
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Immune system disorders
Contrast media allergy
|
0.55%
3/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Immune system disorders
Hypersensitivity
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.0%
1/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.0%
1/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Appendicitis
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Appendicitis perforated
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Bronchitis
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
COVID-19
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Cellulitis
|
0.73%
4/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.0%
1/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Conjunctivitis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Diverticulitis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Encephalitis
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Escherichia infection
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
0.55%
3/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Gastrointestinal fungal infection
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Herpes zoster disseminated
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Infection
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.0%
1/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Infectious mononucleosis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Influenza
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Intestinal sepsis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Laryngitis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.55%
3/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.56%
3/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Meningitis aseptic
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Paronychia
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia
|
5.3%
29/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
2.2%
12/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia aspiration
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia bacterial
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pulmonary sepsis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Respiratory tract infection
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Sepsis
|
2.2%
12/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
1.3%
7/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.0%
1/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Septic shock
|
0.55%
3/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Soft tissue infection
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
1.6%
9/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Urosepsis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Viral infection
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Injury
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Pneumonitis chemical
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Product administration error
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Wound
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
1.8%
10/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
0.91%
5/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood bilirubin increased
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood creatinine increased
|
1.1%
6/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood potassium increased
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Investigations
Influenza A virus test positive
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Investigations
Lipase increased
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Investigations
Liver function test increased
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Investigations
Pancreatic enzymes increased
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Investigations
Platelet count decreased
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.75%
4/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Investigations
Respiratory syncytial virus test positive
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Investigations
Transaminases increased
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Investigations
Troponin increased
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
8/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
2.1%
11/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetic complication
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Fulminant type 1 diabetes mellitus
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.1%
6/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.93%
5/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.3%
7/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.73%
4/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.56%
3/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.0%
11/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.93%
5/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.3%
7/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.55%
3/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
7/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.75%
4/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.55%
3/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.56%
3/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.0%
1/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.73%
4/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.75%
4/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric adenoma
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
8.4%
46/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
13.8%
74/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to adrenals
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.55%
3/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.73%
4/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.75%
4/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to kidney
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.0%
1/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine adenocarcinoma
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour thrombosis
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Aphasia
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Bell's palsy
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Brain oedema
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Central nervous system lesion
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.55%
3/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebral infarction
|
0.55%
3/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.73%
4/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Cervical cord compression
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Encephalopathy
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Facial nerve disorder
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Facial paresis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
0.55%
3/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Hemiplegia
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Ischaemic stroke
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Myasthenia gravis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Paraesthesia
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Paraparesis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Polyneuropathy
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Seizure
|
1.1%
6/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Speech disorder
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Spinal cord compression
|
0.73%
4/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Syncope
|
0.55%
3/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Thecal sac compression
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.0%
1/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Product Issues
Device breakage
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Confusional state
|
1.5%
8/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Delirium
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Depression
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Mental status changes
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Suicide attempt
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.6%
14/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
1.7%
9/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Autoimmune nephritis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Haematuria
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
1.7%
9/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.0%
1/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Micturition urgency
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Nephritis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Polyuria
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Renal failure
|
0.55%
3/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.56%
3/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Renal impairment
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Renal injury
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Urinary retention
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acquired diaphragmatic eventration
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
13/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
2.4%
13/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.56%
3/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.56%
3/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal dyspnoea
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Malignant pleural effusion
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.6%
9/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
2.2%
12/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.3%
18/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.56%
3/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.55%
3/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.56%
3/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.1%
6/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.93%
5/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Reflux laryngitis
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.0%
1/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Social circumstances
Immobile
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Social circumstances
Pregnancy of partner
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Angiopathy
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Deep vein thrombosis
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.56%
3/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Embolism
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Haematoma
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Hypertension
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.56%
3/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Hypotension
|
0.73%
4/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Orthostatic hypotension
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.19%
1/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Shock
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Thrombosis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Vein rupture
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Vena cava thrombosis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Venous occlusion
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Venous thrombosis
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
Other adverse events
| Measure |
Nivolumab + Ipilimumab
n=547 participants at risk
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
|
Sunitinib
n=535 participants at risk
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
|
Sunitinib Crossover
n=25 participants at risk
Participants received Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240 mg flat dose IV every 2 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.6%
91/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
21.7%
116/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
36.0%
9/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.73%
4/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
6.2%
33/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
16.0%
4/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.5%
8/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
14.0%
75/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
20.0%
5/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.9%
16/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
18.9%
101/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Adrenal insufficiency
|
6.2%
34/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hyperthyroidism
|
11.7%
64/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
3.6%
19/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hypothyroidism
|
19.6%
107/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
29.0%
155/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
36.0%
9/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Vision blurred
|
6.2%
34/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
2.1%
11/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.7%
15/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
5.0%
27/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.4%
79/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
17.2%
92/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
24.0%
6/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.9%
32/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.8%
47/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
16.0%
4/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
20.5%
112/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
19.8%
106/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
12.0%
3/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
42.0%
230/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
59.4%
318/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
60.0%
15/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dry mouth
|
7.3%
40/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
7.1%
38/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
34/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
21.3%
114/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
16.0%
4/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Flatulence
|
1.8%
10/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
6.0%
32/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.1%
17/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
13.1%
70/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
12.0%
3/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.7%
15/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
5.0%
27/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.0%
1/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
32.2%
176/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
44.9%
240/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
40.0%
10/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Oral pain
|
0.55%
3/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
5.8%
31/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
7.7%
42/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
29.3%
157/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
36.0%
9/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Toothache
|
2.6%
14/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
5.4%
29/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
12.0%
3/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
21.9%
120/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
30.5%
163/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
40.0%
10/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
General disorders
Asthenia
|
18.3%
100/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
19.4%
104/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
24.0%
6/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
General disorders
Chest pain
|
5.3%
29/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
6.0%
32/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
12.0%
3/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
General disorders
Chills
|
6.2%
34/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
9.0%
48/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
47.3%
259/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
55.3%
296/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
36.0%
9/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
General disorders
Influenza like illness
|
9.5%
52/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
5.8%
31/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
16.0%
4/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
General disorders
Malaise
|
2.6%
14/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
5.0%
27/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
12.0%
3/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
General disorders
Mucosal inflammation
|
4.4%
24/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
29.3%
157/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
32.0%
8/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
General disorders
Oedema peripheral
|
15.9%
87/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
14.0%
75/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
16.0%
4/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
General disorders
Pain
|
7.3%
40/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
9.2%
49/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
12.0%
3/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
General disorders
Pyrexia
|
26.7%
146/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
17.4%
93/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
24.0%
6/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Bronchitis
|
5.3%
29/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
3.9%
21/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
12.0%
3/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
11.2%
61/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.9%
26/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia
|
6.0%
33/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
2.4%
13/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
50/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
7.9%
42/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
6.8%
37/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
5.2%
28/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
12.0%
3/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
14.1%
77/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
12.1%
65/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
20.0%
5/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Investigations
Amylase increased
|
15.5%
85/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.4%
45/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
20.0%
5/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
14.6%
80/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
11.8%
63/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
24.0%
6/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.3%
40/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
5.0%
27/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
12.0%
3/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood creatinine increased
|
14.6%
80/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
10.5%
56/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
20.0%
5/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
2.6%
14/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
6.4%
34/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
20.0%
5/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Investigations
Lipase increased
|
19.7%
108/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
13.5%
72/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
28.0%
7/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Investigations
Neutrophil count decreased
|
2.4%
13/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
7.7%
41/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
32.0%
8/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Investigations
Platelet count decreased
|
3.3%
18/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
15.0%
80/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
40.0%
10/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Investigations
Weight decreased
|
10.8%
59/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
9.0%
48/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Investigations
White blood cell count decreased
|
2.0%
11/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.8%
47/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
28.0%
7/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
24.9%
136/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
31.4%
168/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
28.0%
7/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
32/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.5%
24/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.3%
62/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
5.6%
30/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
12.0%
3/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.2%
45/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.9%
26/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
4.4%
24/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
6.4%
34/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
16.0%
4/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.7%
42/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
6.2%
33/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
16.0%
4/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
30.0%
164/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
21.5%
115/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
36.0%
9/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.7%
113/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
20.0%
107/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
28.0%
7/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.0%
44/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
6.5%
35/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
16.0%
4/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.0%
71/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
7.3%
39/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
16.0%
4/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.3%
73/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
15.9%
85/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
28.0%
7/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
13.2%
72/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
11.8%
63/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
24.0%
6/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Dysgeusia
|
7.1%
39/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
23.0%
123/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
24.0%
6/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
20.7%
113/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
24.7%
132/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
32.0%
8/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Paraesthesia
|
6.8%
37/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
6.2%
33/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.0%
1/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Taste disorder
|
1.5%
8/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
12.7%
68/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
20.0%
5/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
6.9%
38/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.3%
23/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.0%
1/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Depression
|
6.2%
34/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
3.6%
19/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.0%
1/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
13.7%
75/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
7.7%
41/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.2%
165/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
27.7%
148/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
32.0%
8/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
4.8%
26/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
6.5%
35/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.0%
1/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.5%
112/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
18.7%
100/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.2%
12/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
14.8%
79/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
36.0%
9/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.5%
30/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
7.9%
42/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.0%
1/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.5%
30/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.93%
5/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.5%
8/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
5.4%
29/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.3%
62/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
10.8%
58/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
6.0%
32/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
3.5%
19/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
46.0%
246/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
80.0%
20/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
36.4%
199/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
12.9%
69/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
24.0%
6/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
28.3%
155/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
18.1%
97/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
40.0%
10/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.6%
58/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
5.6%
30/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.00%
0/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.91%
5/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
5.4%
29/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.0%
1/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Yellow skin
|
0.00%
0/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.8%
47/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
12.0%
3/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Hypertension
|
13.2%
72/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
45.0%
241/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
60.0%
15/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Ear and labyrinth disorders
Vertigo
|
2.9%
16/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
2.8%
15/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Periorbital oedema
|
0.37%
2/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.1%
22/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.0%
11/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
3.9%
21/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dental caries
|
1.1%
6/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.93%
5/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
General disorders
Face oedema
|
0.55%
3/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
3.4%
18/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.55%
3/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
1.7%
9/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Cystitis
|
1.3%
7/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
1.5%
8/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Folliculitis
|
0.55%
3/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
1.5%
8/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Herpes zoster
|
1.5%
8/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
1.3%
7/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Rhinitis
|
4.9%
27/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
2.2%
12/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Sinusitis
|
4.9%
27/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
2.6%
14/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Tooth infection
|
1.6%
9/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
2.2%
12/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.18%
1/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.9%
16/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
2.4%
13/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
12.0%
3/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.91%
5/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.93%
5/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood bilirubin increased
|
3.7%
20/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.5%
24/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood uric acid increased
|
1.6%
9/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.93%
5/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Investigations
Lymphocyte count decreased
|
2.9%
16/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.5%
24/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
12.0%
3/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.1%
17/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.3%
23/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.4%
24/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
3.2%
17/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.7%
20/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.5%
24/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.73%
4/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
0.37%
2/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.7%
20/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
1.1%
6/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.6%
14/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.5%
24/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.1%
17/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.1%
22/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.5%
8/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
1.7%
9/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Neuropathy peripheral
|
2.2%
12/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
2.2%
12/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.6%
14/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
1.7%
9/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Haematuria
|
3.3%
18/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
4.5%
24/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
12.0%
3/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
2.6%
14/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
2.6%
14/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
8.0%
2/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.8%
10/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
2.1%
11/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
16.0%
4/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.73%
4/547 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
1.5%
8/535 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
12.0%
3/25 • Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email:
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER